A Phase 2/3 interventional study of Naltrexone Hydrochloride and Control in Anorexia Nervosa/Bulimia, Anorexia in Adolescence and Anorexia Nervosa, Atypical, sponsored by Rosemary Claire Roden. Terminated at 1 site in United States. Open to participants aged 13 Years to 25 Years. Per ClinicalTrials.gov, last updated 2025-08-19.
Sponsored by Rosemary Claire Roden · Phase 2/3, Interventional, and Treatment
The objective of this study is to evaluate the effectiveness of oral naltrexone tablets in pediatric and adolescent eating disorders, in particular anorexia nervosa and bulimia nervosa, as compared to placebo. Study participants will be patients in a partial hospitalization program or intensive outpatient program for eating disorder.
Subjects participating in this study will receive routine care for eating disorder at a partial hospitalization (PHP) level of care at MSHMC. In PHP, all patients have weekly medical screening visits for the duration of their time in care, as well as weekly individual therapy sessions, individual dietician sessions, and psychiatry appointments. They have supervised meals and numerous group therapy sessions. Every three weeks, patients in PHP complete a battery of mood and eating disorder indices including those evaluated in this study; participants in this study will complete an additional two surveys with this routine battery. Participants in this study will have no alterations in their routine eating disorder care outside of study article use and these additional surveys.
Subjects will be enrolled at their first visit for eating disorder programming at child or adult partial hospitalization (PHP) programming at MSHMC adolescent medicine eating disorders clinic. Informed consent/assent will be obtained as described above.
The subject will be provided with oral naltrexone or placebo weekly from the MSHMC research pharmacy. Subjects will be given one weeks' worth of medication at a time. Subjects will be randomized at enrollment to receive either study drug (naltrexone) or placebo. Participants or parents of minor participants will be provided study drug or placebo following completion of urine drug screen and consent/assent. Patients will take the medication daily for six weeks. For subjects who are enrolled in child PHP and who eat meals with parents, the families may choose to administer study drug during meals at programming. For adult patients enrolled in adult programming, subjects may choose to self-administer the medication.
On their first contact with PHP, all patients in Child PHP complete various eating disorder indices as a part of routine care, including the ED-15, EDE-Q, RCMAS, CDI, GAD-7, and PHQ-9. This battery of indices is repeated every 3 weeks while a patient is in programming.
For those who are enrolled in this study, they will complete their routine indices, in addition they will also complete the BIS/BAS and the ABUSI at enrollment and at weeks 3, 6, and 9 (after completion of medication) while in programming. Participants will receive routine eating disorder care while in PHP.
Patients in Adult PHP typically complete a different inventory every three weeks. If a patient chooses to participate in this study they will be asked to complete the same surveys as participants in Child PHP, and they will receive the same amount and type of compensation.
Six months after enrollment, subjects will be sent copies of ED-15, EDE-Q, GAD-7, PHQ-9, BIS/BAS, and ABUSI indices either in an in-person medical appointment or via RedCap to complete. If the patient returns for medical follow-up between 5 and 7 months after enrollment, their height, weight, and body mass index will also be recorded to determine if weight restoration was maintained.
At initial contact with the eating disorders clinic, all patients receive an initial battery of laboratory tests as a part of the standard of care for eating disorder. These tests include liver function assays and transaminase levels.
469 studies on the registry are indexed under Anorexia Nervosa; 127 are open to participants now.
This study's enrollment of 9 is below the median of 46 across 313 interventional studies indexed under Anorexia Nervosa.
Browse Anorexia Nervosa studies →This is the only study on the registry with Rosemary Claire Roden as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The diagnostic criteria for anorexia nervosa, binge-purge subtype, are:
A. Restriction of energy intake relative to requirements, leading to a significantly low body weight in the context of age, sex, developmental trajectory, and physical health. Significantly low weight is defined as a weight that is less than minimally normal or, for children and adolescents, less than minimally expected.
B. Intense fear of gaining weight or of becoming fat, or persistent behavior that interferes with weight gain, even though at a significantly low weight.
C. Disturbance in the way in which one's body weight or shape is experienced, undue influence of body weight or shape on self-evaluation, or persistent lack of recognition of the seriousness of the current low body weight D. During the last three months the individual has engaged in recurrent episodes of binge eating or purging behaviour (i.e. self-induced vomiting, or the misuse of laxatives, diuretics, or enemas).19 E. A diagnosis of atypical anorexia nervosa can be made when the body weight is normal or high If these patients engage in bingeing or purging behaviors as defined in anorexia nervosa, binge-purge subtype, they are eligible for inclusion in this study
The diagnostic criteria for bulimia nervosa are:
A. Recurrent episodes of binge eating. An episode of binge eating is characterized by
B. both:
i. Eating in a discrete period of time (e.g. within any 2 hour period), an amount of food that is definitely larger than what most individuals would eat in a similar period of time under similar circumstances; ii. A sense of lack of control over eating during the episodes (e.g. a feeling that one cannot stop eating or control what or how much one is eating.
C. Recurrent inappropriate compensatory behaviors to prevent weight gain, such as self-induced vomiting; misuse of laxatives, diuretics, or other medications; fasting; or excessive exercise.
D. The binge eating and inappropriate compensatory behaviors both occur, on average, at least once a week for 3 months.
E. Self-evaluation is unduly influenced by body shape and weight. F. The disturbance does not occur exclusively during episodes of anorexia nervosa.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler
Drug: Naltrexone Hydrochloride
Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks
Other: Control
25mg x 3 days then 50mg a day thereafter
Methylcellulose and gelatin capsule only
ED-15 Score
ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology.
Time frame: Time Frame: Measured at the following timepoints: enrollment
ED-15 Score
ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology.
Time frame: Time Frame: Measured at the following timepoints: one week
ED-15 Score
ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology.
Time frame: Time Frame: Measured at the following timepoints: three week
ED-15 Score
ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology.
Time frame: Time Frame: Measured at the following timepoints: six weeks
ED-15 Score
ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology.
Time frame: Time Frame: Measured at the following timepoints: nine weeks (last week of treatment)
ED-15 Score
ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology.
Time frame: Time Frame: Measured at the following timepoints: 6 months after enrollment
Eating Disorder Examination Questionnaire Score (EDE-Q)
EDE-Q is an evidence-based metric of eating disorder severity. The global EDE-Q score ranges from 0 to 6, with higher scores indicating a higher eating disorder psychopathology.
Time frame: Measured at the following timepoints: enrollment
Eating Disorder Examination Questionnaire Score (EDE-Q)
EDE-Q is an evidence-based metric of eating disorder severity. The global EDE-Q score ranges from 0 to 6, with higher scores indicating a higher eating disorder psychopathology.
Time frame: Measured at the following timepoints: one week
Eating Disorder Examination Questionnaire Score (EDE-Q)
EDE-Q is an evidence-based metric of eating disorder severity. The global EDE-Q score ranges from 0 to 6, with higher scores indicating a higher eating disorder psychopathology.
Time frame: Measured at the following timepoints: three weeks
Eating Disorder Examination Questionnaire Score (EDE-Q)
EDE-Q is an evidence-based metric of eating disorder severity. The global EDE-Q score ranges from 0 to 6, with higher scores indicating a higher eating disorder psychopathology.
Time frame: Measured at the following timepoints: six weeks
Eating Disorder Examination Questionnaire Score (EDE-Q)
EDE-Q is an evidence-based metric of eating disorder severity. The global EDE-Q score ranges from 0 to 6, with higher scores indicating a higher eating disorder psychopathology.
Time frame: Measured at the following timepoints: nine weeks (last week of treatment)
Eating Disorder Examination Questionnaire Score (EDE-Q)
EDE-Q is an evidence-based metric of eating disorder severity. The global EDE-Q score ranges from 0 to 6, with higher scores indicating a higher eating disorder psychopathology.
Time frame: Measured at the following timepoints: 6 months after enrollment
Patient Health Questionnaire Score (PHQ-9)
Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression
Time frame: Measured at the following timepoints: enrollment
Patient Health Questionnaire Score (PHQ-9)
Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression
Time frame: Measured at the following timepoints: one week
Patient Health Questionnaire Score (PHQ-9)
Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression
Time frame: Measured at the following timepoints: three weeks
Patient Health Questionnaire Score (PHQ-9)
Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression
Time frame: Measured at the following timepoints: six weeks
Patient Health Questionnaire Score (PHQ-9)
Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression
Time frame: Measured at the following timepoints: nine weeks (last week of treatment)
Patient Health Questionnaire Score (PHQ-9)
Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression
Time frame: Measured at the following timepoints: 6 months after enrollment
Generalized Anxiety Disorder Screener Score (GAD-7)
evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety
Time frame: Measured at the following timepoints: enrollment
Generalized Anxiety Disorder Screener Score (GAD-7)
evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety
Time frame: Measured at the following timepoints: one week
Generalized Anxiety Disorder Screener Score (GAD-7)
evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety
Time frame: Measured at the following timepoints: three weeks
Generalized Anxiety Disorder Screener Score (GAD-7)
evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety
Time frame: Measured at the following timepoints: six weeks
Generalized Anxiety Disorder Screener Score (GAD-7)
evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety
Time frame: Measured at the following timepoints: nine weeks (last week of treatment)
Generalized Anxiety Disorder Screener Score (GAD-7)
evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety
Time frame: Measured at the following timepoints: 6 months after enrollment
Alexian Brothers Urge to Self-Injure Scale (ABUSI)
evidence-based metric of urge to self-harm. min = 0 max = 30. Higher scores represent more intense urges to self-injure
Time frame: Measured at the following timepoints: enrollment
Alexian Brothers Urge to Self-Injure Scale (ABUSI)
evidence-based metric of urge to self-harm. min = 0 max = 30. Higher scores represent more intense urges to self-injure
Time frame: Measured at the following timepoints: one week
Alexian Brothers Urge to Self-Injure Scale (ABUSI)
evidence-based metric of urge to self-harm. min = 0 max = 30. Higher scores represent more intense urges to self-injure
Time frame: Measured at the following timepoints: three weeks
Alexian Brothers Urge to Self-Injure Scale (ABUSI)
evidence-based metric of urge to self-harm. min = 0 max = 30. Higher scores represent more intense urges to self-injure
Time frame: Measured at the following timepoints: six weeks
Alexian Brothers Urge to Self-Injure Scale (ABUSI)
evidence-based metric of urge to self-harm. min = 0 max = 30. Higher scores represent more intense urges to self-injure
Time frame: Measured at the following timepoints: nine weeks (last week of treatment)
Alexian Brothers Urge to Self-Injure Scale (ABUSI)
evidence-based metric of urge to self-harm. min = 0 max = 30. Higher scores represent more intense urges to self-injure
Time frame: Measured at the following timepoints: 6 months after enrollment
Barratt Impulsiveness Scale (BIS-11)
Evidence-based metric of impulsivity. min = 30 max = 120. higher scores indicate higher levels of impulsivity.
Time frame: Measured at the following timepoints: enrollment
Barratt Impulsiveness Scale (BIS-11)
Evidence-based metric of impulsivity. min = 30 max = 120. higher scores indicate higher levels of impulsivity.
Time frame: Measured at the following timepoints: one week
Barratt Impulsiveness Scale (BIS-11)
Evidence-based metric of impulsivity. min = 30 max = 120. higher scores indicate higher levels of impulsivity.
Time frame: Measured at the following timepoints: three weeks
Barratt Impulsiveness Scale (BIS-11)
Evidence-based metric of impulsivity. min = 30 max = 120. higher scores indicate higher levels of impulsivity.
Time frame: Measured at the following timepoints: six weeks
Barratt Impulsiveness Scale (BIS-11)
Evidence-based metric of impulsivity. min = 30 max = 120. higher scores indicate higher levels of impulsivity.
Time frame: Measured at the following timepoints: nine weeks (last week of treatment)
Barratt Impulsiveness Scale (BIS-11)
Evidence-based metric of impulsivity. min = 30 max = 120. higher scores indicate higher levels of impulsivity.
Time frame: Measured at the following timepoints: 6 months after enrollment
Percent of Weight Restoration
For participants who need to restore weight, will evaluate the percent of weight gain in care
Time frame: Will evaluate total percent of weight restoration via chart review at 9 weeks
Percent of Weight Restoration
For participants who need to restore weight, will evaluate the percent of weight gain in care
Time frame: Will evaluate total percent of weight restoration via chart review 6 months after enrollment at about 33 weeks
Need For Higher Level of Care
Need to leave the current level of care (where the study is being conducted) to go to a residential, inpatient, or hospital facility
Time frame: Will evaluate need for higher level of care at nine weeks
Need For Higher Level of Care
Need to leave the current level of care (where the study is being conducted) to go to a residential, inpatient, or hospital facility
Time frame: Will evaluate need for higher level of care at 6 months after the end of the study at about 33 weeks
Columbia Suicide Severity Rating Scale (CSSRS)
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk).
Time frame: Measured at enrollment for patients age 17 or older
Columbia Suicide Severity Rating Scale (CSSRS)
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk).
Time frame: week 1 for patients age 17 or older
Columbia Suicide Severity Rating Scale (CSSRS)
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk).
Time frame: week 2 for patients age 17 or older
Columbia Suicide Severity Rating Scale (CSSRS)
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk).
Time frame: week 3 for patients age 17 or older
Columbia Suicide Severity Rating Scale (CSSRS)
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk).
Time frame: week 4 for patients age 17 or older
Columbia Suicide Severity Rating Scale (CSSRS)
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk).
Time frame: week 5 for patients age 17 or older
Columbia Suicide Severity Rating Scale (CSSRS)
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk).
Time frame: week 6 for patients age 17 or older
Columbia Suicide Severity Rating Scale (CSSRS)
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk).
Time frame: week 7 for patients age 17 or older
Columbia Suicide Severity Rating Scale (CSSRS)
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk).
Time frame: week 8 for patients age 17 or older
Columbia Suicide Severity Rating Scale (CSSRS)
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk).
Time frame: week 9 for patients age 17 or older
Columbia Suicide Severity Rating Scale (CSSRS)
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk).
Time frame: 6 months after enrollment for patients age 17 or older
Ask Suicide Screening Questions (ASQ)
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores include 1 (negative screen), 2 (non-acute positive screen), and 3 (acute positive screen). Higher scores represent higher suicidal ideation and higher risk of suicide.
Time frame: Measured at enrollment for patients age 16 or younger
Ask Suicide Screening Questions (ASQ)
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores include 1 (negative screen), 2 (non-acute positive screen), and 3 (acute positive screen). Higher scores represent higher suicidal ideation and higher risk of suicide.
Time frame: week 1 for patients age 16 or younger
Ask Suicide Screening Questions (ASQ)
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores include 1 (negative screen), 2 (non-acute positive screen), and 3 (acute positive screen). Higher scores represent higher suicidal ideation and higher risk of suicide.
Time frame: week 2 for patients age 16 or younger
Ask Suicide Screening Questions (ASQ)
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores include 1 (negative screen), 2 (non-acute positive screen), and 3 (acute positive screen). Higher scores represent higher suicidal ideation and higher risk of suicide.
Time frame: week 3 for patients age 16 or younger
Ask Suicide Screening Questions (ASQ)
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores include 1 (negative screen), 2 (non-acute positive screen), and 3 (acute positive screen). Higher scores represent higher suicidal ideation and higher risk of suicide.
Time frame: week 4 for patients age 16 or younger
Ask Suicide Screening Questions (ASQ)
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores include 1 (negative screen), 2 (non-acute positive screen), and 3 (acute positive screen). Higher scores represent higher suicidal ideation and higher risk of suicide.
Time frame: week 5 for patients age 16 or younger
Ask Suicide Screening Questions (ASQ)
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores include 1 (negative screen), 2 (non-acute positive screen), and 3 (acute positive screen). Higher scores represent higher suicidal ideation and higher risk of suicide.
Time frame: week 6 for patients age 16 or younger
Ask Suicide Screening Questions (ASQ)
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores include 1 (negative screen), 2 (non-acute positive screen), and 3 (acute positive screen). Higher scores represent higher suicidal ideation and higher risk of suicide.
Time frame: week 7 for patients age 16 or younger
Ask Suicide Screening Questions (ASQ)
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores include 1 (negative screen), 2 (non-acute positive screen), and 3 (acute positive screen). Higher scores represent higher suicidal ideation and higher risk of suicide.
Time frame: week 8 for patients age 16 or younger
Ask Suicide Screening Questions (ASQ)
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores include 1 (negative screen), 2 (non-acute positive screen), and 3 (acute positive screen). Higher scores represent higher suicidal ideation and higher risk of suicide.
Time frame: week 9 for patients age 16 or younger
Ask Suicide Screening Questions (ASQ)
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores include 1 (negative screen), 2 (non-acute positive screen), and 3 (acute positive screen). Higher scores represent higher suicidal ideation and higher risk of suicide.
Time frame: 6 months after enrollment for patients age 16 or younger
| Milestone | Intervention | Control |
|---|---|---|
| Started | 5 | 4 |
| Completed | 5 | 4 |
| Not completed | 0 | 0 |
ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology.
| score on a scale | Intervention | Control |
|---|---|---|
| ED-15 Score | 3.5 ± 2.016184515 | 4.7 ± 0.871779789 |
ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology.
| score on a scale | Intervention | Control |
|---|---|---|
| ED-15 Score | 3.08 ± 1.845806057 | 4.675 ± 0.784750491 |
ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology.
| score on a scale | Intervention | Control |
|---|---|---|
| ED-15 Score | 3.04 ± 1.820164828 | 4.025 ± 1.508586535 |
ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology.
| score on a scale | Intervention | Control |
|---|---|---|
| ED-15 Score | 1.825 ± 1.701714821 | 3.5 ± 2.364318084 |
ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology.
| score on a scale | Intervention | Control |
|---|---|---|
| ED-15 Score | 1.075 ± 0.736545993 | 4.5 ± 0 |
ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology.
| score on a scale | Intervention | Control |
|---|---|---|
| ED-15 Score | 0.866666667 ± 0.776745347 | 4.3 ± 0 |
EDE-Q is an evidence-based metric of eating disorder severity. The global EDE-Q score ranges from 0 to 6, with higher scores indicating a higher eating disorder psychopathology.
| score on a scale | Intervention | Control |
|---|---|---|
| Eating Disorder Examination Questionnaire Score (EDE-Q) | 3.3925 ± 1.8216 | 4.72031 ± 0.806764613 |
EDE-Q is an evidence-based metric of eating disorder severity. The global EDE-Q score ranges from 0 to 6, with higher scores indicating a higher eating disorder psychopathology.
| score on a scale | Intervention | Control |
|---|---|---|
| Eating Disorder Examination Questionnaire Score (EDE-Q) | 2.87 ± 1.744810385 | 4.315625 ± 0.645285386 |
EDE-Q is an evidence-based metric of eating disorder severity. The global EDE-Q score ranges from 0 to 6, with higher scores indicating a higher eating disorder psychopathology.
| score on a scale | Intervention | Control |
|---|---|---|
| Eating Disorder Examination Questionnaire Score (EDE-Q) | 2.66375 ± 1.553369573 | 3.9953125 ± 1.634008483 |
EDE-Q is an evidence-based metric of eating disorder severity. The global EDE-Q score ranges from 0 to 6, with higher scores indicating a higher eating disorder psychopathology.
| score on a scale | Intervention | Control |
|---|---|---|
| Eating Disorder Examination Questionnaire Score (EDE-Q) | 1.6546875 ± 1.524132053 | 3.2 ± 2.385773263 |
EDE-Q is an evidence-based metric of eating disorder severity. The global EDE-Q score ranges from 0 to 6, with higher scores indicating a higher eating disorder psychopathology.
| score on a scale | Intervention | Control |
|---|---|---|
| Eating Disorder Examination Questionnaire Score (EDE-Q) | 0.753125 ± 0.538770301 | 4.04375 ± 0 |
EDE-Q is an evidence-based metric of eating disorder severity. The global EDE-Q score ranges from 0 to 6, with higher scores indicating a higher eating disorder psychopathology.
| score on a scale | Intervention | Control |
|---|---|---|
| Eating Disorder Examination Questionnaire Score (EDE-Q) | 2.4125 ± 0.724577822 | 3.90625 ± 0 |
Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression
| score on a scale | Intervention | Control |
|---|---|---|
| Patient Health Questionnaire Score (PHQ-9) | 13.8 ± 8.043631021 | 12 ± 4.966554809 |
Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression
| score on a scale | Intervention | Control |
|---|---|---|
| Patient Health Questionnaire Score (PHQ-9) | 12.8 ± 8.167006796 | 11.5 ± 4.203173404 |
Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression
| score on a scale | Intervention | Control |
|---|---|---|
| Patient Health Questionnaire Score (PHQ-9) | 10.4 ± 6.268971207 | 10.75 ± 4.991659711 |
Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression
| score on a scale | Intervention | Control |
|---|---|---|
| Patient Health Questionnaire Score (PHQ-9) | 7.5 ± 4.434711565 | 10.66666667 ± 2.309401077 |
Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression
| score on a scale | Intervention | Control |
|---|---|---|
| Patient Health Questionnaire Score (PHQ-9) | 5.5 ± 6.191391874 | 12.5 ± 9.192388155 |
Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression
| score on a scale | Intervention | Control |
|---|---|---|
| Patient Health Questionnaire Score (PHQ-9) | 4.666666667 ± 5.507570547 | 4 ± 0 |
evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety
| score on a scale | Intervention | Control |
|---|---|---|
| Generalized Anxiety Disorder Screener Score (GAD-7) | 10.8 ± 3.271085447 | 13.75 ± 5.560275773 |
evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety
| score on a scale | Intervention | Control |
|---|---|---|
| Generalized Anxiety Disorder Screener Score (GAD-7) | 7.4 ± 3.577708764 | 12.75 ± 4.716990566 |
evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety
| score on a scale | Intervention | Control |
|---|---|---|
| Generalized Anxiety Disorder Screener Score (GAD-7) | 6.8 ± 4.438468204 | 11 ± 4.69041576 |
evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety
| score on a scale | Intervention | Control |
|---|---|---|
| Generalized Anxiety Disorder Screener Score (GAD-7) | 6.75 ± 4.645786622 | 10.33333333 ± 3.511884584 |
evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety
| score on a scale | Intervention | Control |
|---|---|---|
| Generalized Anxiety Disorder Screener Score (GAD-7) | 6 ± 6.976149845 | 9 ± 5.656854249 |
evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety
| score on a scale | Intervention | Control |
|---|---|---|
| Generalized Anxiety Disorder Screener Score (GAD-7) | 5.666666667 ± 1.154700538 | 6 ± 0 |
evidence-based metric of urge to self-harm. min = 0 max = 30. Higher scores represent more intense urges to self-injure
| score on a scale | Intervention | Control |
|---|---|---|
| Alexian Brothers Urge to Self-Injure Scale (ABUSI) | 3.4 ± 3.435112807 | 7.25 ± 7.632168761 |
evidence-based metric of urge to self-harm. min = 0 max = 30. Higher scores represent more intense urges to self-injure
| score on a scale | Intervention | Control |
|---|---|---|
| Alexian Brothers Urge to Self-Injure Scale (ABUSI) | 3.6 ± 4.098780306 | 5.75 ± 4.924428901 |
evidence-based metric of urge to self-harm. min = 0 max = 30. Higher scores represent more intense urges to self-injure
| score on a scale | Intervention | Control |
|---|---|---|
| Alexian Brothers Urge to Self-Injure Scale (ABUSI) | 2.8 ± 2.387467277 | 4.5 ± 3.415650255 |
evidence-based metric of urge to self-harm. min = 0 max = 30. Higher scores represent more intense urges to self-injure
| score on a scale | Intervention | Control |
|---|---|---|
| Alexian Brothers Urge to Self-Injure Scale (ABUSI) | 2.25 ± 2.62995564 | 11 ± 6.08276253 |
evidence-based metric of urge to self-harm. min = 0 max = 30. Higher scores represent more intense urges to self-injure
| score on a scale | Intervention | Control |
|---|---|---|
| Alexian Brothers Urge to Self-Injure Scale (ABUSI) | 1.5 ± 3 | 9 ± 12.72792206 |
evidence-based metric of urge to self-harm. min = 0 max = 30. Higher scores represent more intense urges to self-injure
| score on a scale | Intervention | Control |
|---|---|---|
| Alexian Brothers Urge to Self-Injure Scale (ABUSI) | 0.333333333 ± 0.577350269 | 0 ± 0 |
Evidence-based metric of impulsivity. min = 30 max = 120. higher scores indicate higher levels of impulsivity.
| score on a scale | Intervention | Control |
|---|---|---|
| Barratt Impulsiveness Scale (BIS-11) | 62.2 ± 14.44645285 | 72.25 ± 9.569918147 |
Evidence-based metric of impulsivity. min = 30 max = 120. higher scores indicate higher levels of impulsivity.
| score on a scale | Intervention | Control |
|---|---|---|
| Barratt Impulsiveness Scale (BIS-11) | 64 ± 17.88854382 | 71 ± 6.976149845 |
Evidence-based metric of impulsivity. min = 30 max = 120. higher scores indicate higher levels of impulsivity.
| score on a scale | Intervention | Control |
|---|---|---|
| Barratt Impulsiveness Scale (BIS-11) | 64.4 ± 12.77888884 | 69.5 ± 5.744562647 |
Evidence-based metric of impulsivity. min = 30 max = 120. higher scores indicate higher levels of impulsivity.
| score on a scale | Intervention | Control |
|---|---|---|
| Barratt Impulsiveness Scale (BIS-11) | 65.25 ± 14.22146265 | 69.66666667 ± 6.506407099 |
Evidence-based metric of impulsivity. min = 30 max = 120. higher scores indicate higher levels of impulsivity.
| score on a scale | Intervention | Control |
|---|---|---|
| Barratt Impulsiveness Scale (BIS-11) | 63.25 ± 14.97497913 | 71 ± 12.72792206 |
Evidence-based metric of impulsivity. min = 30 max = 120. higher scores indicate higher levels of impulsivity.
| score on a scale | Intervention | Control |
|---|---|---|
| Barratt Impulsiveness Scale (BIS-11) | 64 ± 10.58300524 | 60 ± 0 |
For participants who need to restore weight, will evaluate the percent of weight gain in care
| percentage of weight restoration | Intervention | Control |
|---|---|---|
| Percent of Weight Restoration | 100.25 ± 5.068 | 94 ± 12 |
For participants who need to restore weight, will evaluate the percent of weight gain in care
| percentage of weight restoration | Intervention | Control |
|---|---|---|
| Percent of Weight Restoration | 100.5 ± 10.60660172 | 84.5 ± 7.778174593 |
Need to leave the current level of care (where the study is being conducted) to go to a residential, inpatient, or hospital facility
| Participants | Intervention | Control |
|---|---|---|
| Need for Higher Level of Care | 0 | 0 |
| No Need for Higher Level of Care | 4 | 4 |
Need to leave the current level of care (where the study is being conducted) to go to a residential, inpatient, or hospital facility
| Participants | Intervention | Control |
|---|---|---|
| Need for Higher Level of Care | 0 | 1 |
| No Need for Higher Level of Care | 2 | 0 |
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk).
| Participants | Intervention | Control |
|---|---|---|
| Low Risk | 0 | 1 |
| Medium Risk | 1 | 1 |
| High Risk | 0 | 0 |
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk).
| Participants | Intervention | Control |
|---|---|---|
| Low Risk | 1 | 1 |
| Medium Risk | 0 | 1 |
| High Risk | 0 | 0 |
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk).
| Participants | Intervention | Control |
|---|---|---|
| Low Risk | 0 | 1 |
| Medium Risk | 1 | 1 |
| High Risk | 0 | 0 |
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk).
| Participants | Intervention | Control |
|---|---|---|
| Low Risk | 1 | 2 |
| Medium Risk | 0 | 0 |
| High Risk | 0 | 0 |
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk).
| Participants | Intervention | Control |
|---|---|---|
| Low Risk | 0 | 1 |
| Medium Risk | 1 | 0 |
| High Risk | 0 | 0 |
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk).
| Participants | Intervention | Control |
|---|---|---|
| Low Risk | 0 | 1 |
| Medium Risk | 1 | 0 |
| High Risk | 0 | 0 |
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk).
| Participants | Intervention | Control |
|---|---|---|
| Low Risk | 0 | 0 |
| Medium Risk | 1 | 0 |
| High Risk | 0 | 0 |
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk).
No measurements were reported for this outcome.
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk).
No measurements were reported for this outcome.
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk).
No measurements were reported for this outcome.
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk).
No measurements were reported for this outcome.
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores include 1 (negative screen), 2 (non-acute positive screen), and 3 (acute positive screen). Higher scores represent higher suicidal ideation and higher risk of suicide.
| Participants | Intervention | Control |
|---|---|---|
| Negative Screen | 1 | 2 |
| Non-Acute Positive Screen | 3 | 0 |
| Acute Positive Screen | 0 | 0 |
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores include 1 (negative screen), 2 (non-acute positive screen), and 3 (acute positive screen). Higher scores represent higher suicidal ideation and higher risk of suicide.
| Participants | Intervention | Control |
|---|---|---|
| Negative Screen | 1 | 1 |
| Non-Acute Positive Screen | 3 | 1 |
| Acute Positive Screen | 0 | 0 |
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores include 1 (negative screen), 2 (non-acute positive screen), and 3 (acute positive screen). Higher scores represent higher suicidal ideation and higher risk of suicide.
| Participants | Intervention | Control |
|---|---|---|
| Negative Screen | 1 | 1 |
| Non-Acute Positive Screen | 3 | 1 |
| Acute Positive Screen | 0 | 0 |
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores include 1 (negative screen), 2 (non-acute positive screen), and 3 (acute positive screen). Higher scores represent higher suicidal ideation and higher risk of suicide.
| Participants | Intervention | Control |
|---|---|---|
| Negative Screen | 1 | 1 |
| Non-Acute Positive Screen | 3 | 1 |
| Acute Positive Screen | 0 | 0 |
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores include 1 (negative screen), 2 (non-acute positive screen), and 3 (acute positive screen). Higher scores represent higher suicidal ideation and higher risk of suicide.
| Participants | Intervention | Control |
|---|---|---|
| Negative Screen | 2 | 2 |
| Non-Acute Positive Screen | 0 | 0 |
| Acute Positive Screen | 0 | 0 |
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores include 1 (negative screen), 2 (non-acute positive screen), and 3 (acute positive screen). Higher scores represent higher suicidal ideation and higher risk of suicide.
| Participants | Intervention | Control |
|---|---|---|
| Negative Screen | 1 | 2 |
| Non-Acute Positive Screen | 1 | 0 |
| Acute Positive Screen | 0 | 0 |
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores include 1 (negative screen), 2 (non-acute positive screen), and 3 (acute positive screen). Higher scores represent higher suicidal ideation and higher risk of suicide.
| Participants | Intervention | Control |
|---|---|---|
| Negative Screen | 2 | 2 |
| Non-Acute Positive Screen | 1 | 0 |
| Acute Positive Screen | 0 | 0 |
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores include 1 (negative screen), 2 (non-acute positive screen), and 3 (acute positive screen). Higher scores represent higher suicidal ideation and higher risk of suicide.
No measurements were reported for this outcome.
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores include 1 (negative screen), 2 (non-acute positive screen), and 3 (acute positive screen). Higher scores represent higher suicidal ideation and higher risk of suicide.
| Participants | Intervention | Control |
|---|---|---|
| Low Risk | 2 | 1 |
| Medium Risk | 1 | 0 |
| High Risk | 0 | 0 |
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores include 1 (negative screen), 2 (non-acute positive screen), and 3 (acute positive screen). Higher scores represent higher suicidal ideation and higher risk of suicide.
| Participants | Intervention | Control |
|---|---|---|
| Negative Screen | 2 | 1 |
| Non-Acute Positive Screen | 1 | 0 |
| Acute Positive Screen | 0 | 0 |
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores include 1 (negative screen), 2 (non-acute positive screen), and 3 (acute positive screen). Higher scores represent higher suicidal ideation and higher risk of suicide.
| Participants | Intervention | Control |
|---|---|---|
| Negative Screen | 2 | 1 |
| Non-Acute Positive Screen | 0 | 0 |
| Acute Positive Screen | 0 | 0 |
Collected over Up to 33 weeks for each participant.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | 0/5 (0%) | 0/5 (0%) | 3/5 (60%) |
| Control | 0/4 (0%) | 1/4 (25%) | 4/4 (100%) |
| Event | Intervention | Control |
|---|---|---|
| Motor Vehicle AccidentMusculoskeletal and connective tissue disorders | 0/5 | 1/4 |
| Event | Intervention | Control |
|---|---|---|
| Sore throat, runny nose, congestionInfections and infestations | 0/5 | 2/4 |
| NauseaGastrointestinal disorders | 2/5 | 0/4 |
| HeadacheGeneral disorders | 0/5 | 1/4 |
| Urinary Tract InfectionRenal and urinary disorders | 0/5 | 1/4 |
| ConstipationGastrointestinal disorders | 0/5 | 1/4 |
| FeverImmune system disorders | 0/5 | 1/4 |
| Increase in MedicationPsychiatric disorders | 1/5 | 0/4 |
| Less HeadachesGeneral disorders | 1/5 | 0/4 |
| SweatingEndocrine disorders | 1/5 | 0/4 |
| Age, Continuous(years) | Intervention | Control | Total |
|---|---|---|---|
| Mean | 16 (14 to 17) | 17 (15.25 to 19.25) | 16.5 (14 to 18) |
| Sex: Female, Male(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Female | 5 | 4 | 9 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Intervention | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 4 | 1 | 5 |
| More than one race | 1 | 1 | 2 |
| Unknown or Not Reported | 0 | 2 | 2 |
| Race/Ethnicity, Customized(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Non-Hispanic | 5 | 1 | 6 |
| Hispanic | 0 | 0 | 0 |
| Multiple | 0 | 1 | 1 |
| Unknown | 0 | 2 | 2 |
| Region of Enrollment(Participants) | Intervention | Control | Total |
|---|---|---|---|
| United States | 5 | 4 | 9 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — No participant data is planned to be shared at the moment to protect patient privacy, as participants are all enrolled in a partial hospitalization program for mental health conditions.
This study is terminated, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Naltrexone