A Phase 2 interventional study of Rexulti and Placebo in Borderline Personality Disorder, sponsored by University of Chicago. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-03-18.
Sponsored by University of Chicago · Phase 2, Interventional, and Treatment
Among 81 studies in Borderline Personality Disorder with a site in United States — 15 open to participants now, 17 under way, none of them phase 3. Borderline Personality Disorder · United States.
Among the 81 studies in Borderline Personality Disorder with a site in United States, this one is the 26th largest by enrollment of the 71 interventional ones that give a count, is one of 2 that started in 2018, is one of 16 in phase 2, and was the 44th registered.
278 studies on the registry are indexed under Borderline Personality Disorder; 70 are open to participants now.
Browse Borderline Personality Disorder studies →15 of the 81 studies in Borderline Personality Disorder with a site in United States are open now. Recruiting first, the newest first:
Massachusetts General Hospital · Sites in United States
Ages 22–65
Mclean Hospital · Sites in United States
Ages 18+
Yale University · Sites in United States
Ages 18–60
University of California, Los Angeles · Sites in United States
Ages 18–65
Icahn School of Medicine at Mount Sinai · Sites in United States
Ages 18–55
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 49 Borderline Personality Disorder studies recruiting now, 18 (37%) set no upper age limit and 30 (61%) stop at 75 or younger; 8 take children under 18; 11 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
81 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 19 · Phase 3 6 · Phase 4 6
First in 1997; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 80 is above the median of 70 across 221 interventional studies indexed under Borderline Personality Disorder.
Median enrollment 56 across the 71 interventional studies, 48 across the 7 observational. Of the 57 that completed or were terminated, 22 (39%) have results posted.
This tab as a report to print or save as PDF → With an account.
9 of 81 have an industry lead sponsor. The 10 most frequent:
University of Chicago is the lead sponsor of 924 studies on the registry; 186 are open to participants now.
Of its 103 completed or terminated interventional studies of FDA-regulated products, 72 (70%) have results posted.
University of Chicago has 4 studies filed under Borderline Personality Disorder — fewer than ten, so there is no comparison to draw.
7 of the studies in Borderline Personality Disorder with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04870255Stanford UniversityTreatment of Acute Mood Depressive Episode in Borderline Personality Disorder With rTMS | 2026-12 |
| NCT05651295Matthew Southward, PhDA Precision Medicine Approach to Target Engagement for Emotion Regulation | 2026-12-31 |
| NCT06683014Yale UniversityMDMA in Borderline Personality Disorder | 2027-06 |
| NCT07460947Mclean HospitalA Pilot Trial of One-Day Accelerated TMS and D-cycloserine in Suicidal Patients With Borderline Personality Disorder | 2027-06 |
| NCT06772831Icahn School of Medicine at Mount SinaiCognitive Reappraisal Training for Borderline Personality (BPD) | 2027-07-31 |
Add all 7 to your calendar (.ics) → With an account.
Among the 81 studies in Borderline Personality Disorder with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The primary objective of the proposed study is to evaluate the safety and efficacy of Brexpiprazole in adults with borderline personality disorder (BPD). The hypothesis to be tested is that brexpiprazole will be more effective and well tolerated in adults with BPD compared to placebo. The proposed study will provide needed data on the treatment of a disabling disorder.
Borderline personality disorder is characterized by mood instability, cognitive symptoms, impulsive behavior, and disturbed relationships (1-3). A variety of psychotherapies have been developed (4-6) and, while research on the use of medication is ongoing, no drug has been approved in the United States or elsewhere for its treatment (7). Second generation antipsychotics have been the most intensively studied (8-11). Current treatments for BPD are often inadequate. Dialectical behavioral therapy has been shown to reduce BPD but finding trained psychologists is difficult.
Dysfunctions in the serotoninergic and dopaminergic systems have been demonstrated in-and considered as possible causes for-symptoms associated with the disorder (25-28). Several studies on the use of traditional (29) and atypical antipsychotic agents in patients with borderline personality disorder (30-31) have shown a positive effect on individual symptoms (29, 32-36). However, we are not aware of any study evaluating Brexpiprazole in the treatment of patients with borderline personality disorder. In the proposed double-blind, placebo-controlled study, the influence of Brexpiprazole on the multifaceted psychopathological symptoms and aggression of patients with borderline personality disorder will be investigated.
Brexpiprazole therefore has distinctive properties that make it a promising option for patients with BPD. Brexpiprazole is a novel D2 partial agonist, has affinity for 5-HT1A, acts as an antagonist of the noradrenergic α1/2 receptor, partial agonist for D3, and antagonist for 5-HT2A (37-39). In addition, because of low rates of side effects, Brexpiprazole should be a well-tolerated and in fact desired medication approach to BPD.
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.
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1 milligram per day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods.
Drug: Placebo
1 milligram per day day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods.
Drug: Rexulti
Atypical antipsychotic
Also known as: Brexpiprazole
Pill that contains no medicine
Also known as: no other names
Zanarini Rating Scale for Borderline Personality Disorder
A clinician-administered scale assessing Borderline Personality Scale severity at all study visits. Scores range from 0-36. Higher scores represent worse Borderline Personality Disorder severity, and lower scores represent milder Borderline Personality Disorder severity.
Time frame: Baseline (Visit 1), Week 1 (Visit 2), Week 2 (Visit 3), Week 4 (Visit 4), Week 6 (Visit 5), Week 8 (Visit 6), Week 10 (Visit 7), Week 12 (Visit 8)
Modified Overt Aggression Scale (MOAS)
A clinician-administered behavior rating scale measuring four types of aggressive behavior that will be assessed at all 9 visits. The subsets range on a scale from 0-4 with 0 indicating no aggression present. This scale tracks changes in level of aggression over time. The total weighted sum of the sections of the scale is recorded. Higher total scores indicate higher aggression levels.
Time frame: Baseline (Visit 1), Week 1 (Visit 2), Week 2 (Visit 3), Week 4 (Visit 4), Week 6 (Visit 5), Week 8 (Visit 6), Week 10 (Visit 7), Week 12 (Visit 8)
Young Mania Rating Scale
A clinician-administered, 11 item scale that assesses manic symptoms at baseline and over time. Higher total scores indicate higher severity of manic symptoms. This scale is used to rate the severity of manic abnormality in the patient. Subsets of the scale range from 0-4 with 0 indicating no severity. This scale will be assessed at all visits.
Time frame: Baseline (Visit 1), Week 1 (Visit 2), Week 2 (Visit 3), Week 4 (Visit 4), Week 6 (Visit 5), Week 8 (Visit 6), Week 10 (Visit 7), Week 12 (Visit 8)
Self Report Version of Zanarini Scale
A self-report scale assessing Borderline Personality severity that will be assessed at all visits.This scale is assessing severity and change in BPD symptoms. This is a 9-item scale measuring severity of different aspects of Borderline Personality Disorder, with each item rated on a 0-4 scale, 0=no symptoms, 4=severe symptoms. Total scores range from 0-36.
Time frame: Baseline (Visit 1), Week 1 (Visit 2), Week 2 (Visit 3), Week 4 (Visit 4), Week 6 (Visit 5), Week 8 (Visit 6), Week 10 (Visit 7), Week 12 (Visit 8)
Borderline Evaluation of Severity Over Time (BEST)
A self rated scale used to measure severity and change. The first 12 items of the scale are on a scale from 1-5, with 5 meaning that the item caused extreme distress, severe difficulties in relationships, and/or kept them from getting things done. The lowest rating (1) means it caused little or no problems. Items 13-15 (positive behaviors) are rated according to frequency. Completed at every visit.
Time frame: Assessed at Visits 1 to 8, change in scores from Visit 1 to Visit 8 (baseline to week 12) is reported
Barratt Impulsiveness Scale (BIS)
A self-report assessment of impulsivity that will be assessed at baseline and visit 8. The BIS is composed of 30 items describing common impulsive or non-impulsive (for reverse scored items) behaviors and preferences. Items are scored on a 4-point scale: (Rarely/Never = 1, Occasionally = 2, Often = 3, Almost Always/Always = 4). These scores are summed to produce an overall impulsivity score ranging from 30 (not impulsive) to 120 (extremely impulsive).
Time frame: Baseline (Visit 1), Week 12 (Visit 8)
Symptom Checklist-90 Revised
An instrument that helps evaluate a broad range of psychological problems and symptoms of Borderline Personality Disorder psychopathology. This will be assessed at baseline and visit 8.The 115 items are rated by using a 5-step Likert scale (0=not at all, 4=very strong) and provide a global picture of borderline psychopathology. Global scores of borderline psychopathology are calculated by summing 12 items and range from 0-48. Higher scores indicate more severe symptoms of Borderline Personality Disorder.
Time frame: Baseline, Visit 8 (Week 12)
Hamilton Anxiety Rating Scale (HAM-A)
A clinician-administered assessment of anxiety that will be assessed at all study visits (Visit 1-Visit 8). Changes in scores from baseline to final visit will be assessed. Higher scores (up to 56) indicate higher levels of anxiety, with 0 being no symptoms of anxiety.
Time frame: assessed at Visits 1 to 8, change in scores from Visit 1 to Visit 8 (baseline to Week 12) is reported
Hamilton Depression Rating Scale (HAM-D)
A clinician-administered assessment of depression that will be assessed at all study visits (Visits 1-8). Higher total scores indicate higher levels of depression (up to 52), while a score of 0 would indicate no depressive symptoms.
Time frame: Assessed at Visits 1 to 8, change in scores from Visit 1 to Visit 8 (baseline to week 12) is reported
MINI International Neuropsychiatric Interview
A short-structured interview that assesses comorbid psychiatric disorders according to the DSM 5 criteria. This assessment will be done during the baseline visit.
Time frame: Baseline (Week 1)
Sheehan Disability Scale (SDS)
Subjects will complete the SDS at all visits. The change in scores from baseline to study completion will be assessed. The scale itself assesses the level of disability from borderline personality disorder (or target disorder) with higher scores indicating a more debilitating disorder. Scores range from 0-30.
Time frame: Baseline (Visit 1), Week 1 (Visit 2), Week 2 (Visit 3), Week 4 (Visit 4), Week 6 (Visit 5), Week 8 (Visit 6), Week 10 (Visit 7), Week 12 (Visit 8)
Quality of Life Inventory (QOLI)
A self-report assessment of patient perceived quality of life that will be assessed at baseline and visit 8. Higher scores indicate a higher quality of life, whereas lower scores indicate a lower quality of life. Participants are asked to rate the importance of each domain on a 3-point scale ranging from 1=not important to 3=very important, and to rate how satisfied they are with that domain on a 6-point scale, ranging from -3=very dissatisfied to +3=very satisfied. In scoring, importance ratings are multiplied by satisfaction ratings to produce weighted satisfaction scores for each of the 16 domains. Weighted satisfaction scores are summed and divided by the number of domains that were rated as important or very important to produce a raw score, which is then converted to a t-score, which provides a proxy measurement for perceived quality of life. T-scores range from very low perceived quality of life (0-36) to high perceived quality of life (58-77).
Time frame: Baseline (Week 1), Week 12 (Visit 8)
Columbia Suicide Severity Rating Scale (CSSRS)
A self-report scale measuring suicidality. Subjects will complete the scale at all visits. Subjects are asked about suicidal thoughts. If answers are no, rater can proceed to "suicidal behavior" section where subject is asked about any non-suicidal self injurious behavior. If yes, subject is asked about intensity of ideations. In the event of serious threat to themselves, the subject will be escorted to the emergency room. Total score indicates severity of suicidal ideation and behavior, with lower scores representing lower levels of suicidality and higher scores representing higher levels of suicidality. A score of 0 would reflect no suicidality present, whereas a maximum score of 5 would reflect active suicidal ideation with intent to act.
Time frame: Baseline (Visit 1), Week 12 (Visit 8)
| Milestone | Placebo | Rexulti |
|---|---|---|
| Started | 40 | 40 |
| Completed all baseline measures | 37 | 40 |
| Completed one-post randomization visit | 34 | 35 |
| Completed | 25 | 30 |
| Not completed | 15 | 10 |
| Withdrew: Lost to follow-up | 13 | 10 |
| Withdrew: Adverse event | 2 | 0 |
A clinician-administered scale assessing Borderline Personality Scale severity at all study visits. Scores range from 0-36. Higher scores represent worse Borderline Personality Disorder severity, and lower scores represent milder Borderline Personality Disorder severity.
| score on a scale | Placebo | Rexulti |
|---|---|---|
| Visit 1 | 14.9 (9 to 26) | 14.9 (9 to 26) |
| Visit 2 | 7.6 (0 to 19) | 6.7 (0 to 20) |
| Visit 3 | 4.7 (0 to 16) | 5.3 (0 to 17) |
| Visit 4 | 6 (0 to 18) | 4.4 (0 to 19) |
| Visit 5 | 4.2 (0 to 15) | 4.5 (0 to 20) |
| Visit 6 | 5.7 (0 to 14) | 4.9 (0 to 19) |
| Visit 7 | 5 (0 to 16) | 4 (0 to 25) |
| Visit 8 | 8.4 (0 to 22) | 3.1 (0 to 18) |
A clinician-administered behavior rating scale measuring four types of aggressive behavior that will be assessed at all 9 visits. The subsets range on a scale from 0-4 with 0 indicating no aggression present. This scale tracks changes in level of aggression over time. The total weighted sum of the sections of the scale is recorded. Higher total scores indicate higher aggression levels.
No measurements were reported for this outcome.
A clinician-administered, 11 item scale that assesses manic symptoms at baseline and over time. Higher total scores indicate higher severity of manic symptoms. This scale is used to rate the severity of manic abnormality in the patient. Subsets of the scale range from 0-4 with 0 indicating no severity. This scale will be assessed at all visits.
No measurements were reported for this outcome.
A self-report scale assessing Borderline Personality severity that will be assessed at all visits.This scale is assessing severity and change in BPD symptoms. This is a 9-item scale measuring severity of different aspects of Borderline Personality Disorder, with each item rated on a 0-4 scale, 0=no symptoms, 4=severe symptoms. Total scores range from 0-36.
| score on a scale | Placebo | Rexulti |
|---|---|---|
| Visit 1 | 18.2 (8 to 36) | 17.6 (8 to 36) |
| Visit 2 | 12.8 (0 to 36) | 10.9 (0 to 36) |
| Visit 3 | 10.7 (0 to 36) | 7.9 (0 to 36) |
| Visit 4 | 10.7 (0 to 36) | 8.0 (0 to 36) |
| Visit 5 | 9.7 (0 to 36) | 7.0 (0 to 36) |
| Visit 6 | 9.6 (0 to 36) | 6.6 (0 to 36) |
| Visit 7 | 8.7 (0 to 36) | 6.0 (0 to 36) |
| Visit 8 | 9.3 (0 to 36) | 5.8 (0 to 36) |
A self rated scale used to measure severity and change. The first 12 items of the scale are on a scale from 1-5, with 5 meaning that the item caused extreme distress, severe difficulties in relationships, and/or kept them from getting things done. The lowest rating (1) means it caused little or no problems. Items 13-15 (positive behaviors) are rated according to frequency. Completed at every visit.
| score on a scale | Placebo | Rexulti |
|---|---|---|
| Visit 1 | 40.90 ± 10.91 | 40.54 ± 8.25 |
| Visit 8 | 29.15 ± 8.37 | 23.15 ± 9.06 |
A self-report assessment of impulsivity that will be assessed at baseline and visit 8. The BIS is composed of 30 items describing common impulsive or non-impulsive (for reverse scored items) behaviors and preferences. Items are scored on a 4-point scale: (Rarely/Never = 1, Occasionally = 2, Often = 3, Almost Always/Always = 4). These scores are summed to produce an overall impulsivity score ranging from 30 (not impulsive) to 120 (extremely impulsive).
| score on a scale | Placebo | Rexulti |
|---|---|---|
| Visit 1 | 76.53 ± 15.33 | 72.27 ± 15.50 |
| Visit 8 | 68.13 ± 13.89 | 70.5 ± 17.86 |
An instrument that helps evaluate a broad range of psychological problems and symptoms of Borderline Personality Disorder psychopathology. This will be assessed at baseline and visit 8.The 115 items are rated by using a 5-step Likert scale (0=not at all, 4=very strong) and provide a global picture of borderline psychopathology. Global scores of borderline psychopathology are calculated by summing 12 items and range from 0-48. Higher scores indicate more severe symptoms of Borderline Personality Disorder.
| score on a scale | Placebo | Rexulti |
|---|---|---|
| Visit 1 | 26.17 ± 10.44 | 25.42 ± 11.58 |
| Visit 8 | 20.25 ± 7.99 | 14.21 ± 10.88 |
A clinician-administered assessment of anxiety that will be assessed at all study visits (Visit 1-Visit 8). Changes in scores from baseline to final visit will be assessed. Higher scores (up to 56) indicate higher levels of anxiety, with 0 being no symptoms of anxiety.
| change in score on a scale | Placebo | Rexulti |
|---|---|---|
| Hamilton Anxiety Rating Scale (HAM-A) | -2.41 ± 8.43 | -4.88 ± 7.46 |
A clinician-administered assessment of depression that will be assessed at all study visits (Visits 1-8). Higher total scores indicate higher levels of depression (up to 52), while a score of 0 would indicate no depressive symptoms.
| change in score on a scale | Placebo | Rexulti |
|---|---|---|
| Hamilton Depression Rating Scale (HAM-D) | -2.09 ± 6.91 | -3.81 ± 7.41 |
A short-structured interview that assesses comorbid psychiatric disorders according to the DSM 5 criteria. This assessment will be done during the baseline visit.
| Participants | Placebo | Rexulti |
|---|---|---|
| Major Depressive Episode (Current) | 16 | 18 |
| Major Depressive Episode (Past) | 12 | 18 |
| Manic Episode (Current) | 2 | 2 |
| Manic Episode (Past) | 1 | 3 |
| Hypomanic Episode (Current) | 1 | 0 |
| Bipolar I Disorder (Current) | 0 | 0 |
| Bipolar I Disorder (Past) | 0 | 0 |
| Bipolar II Disorder (Current) | 0 | 0 |
| Bipolar II Disorder (Past) | 0 | 1 |
| Panic Disorder (Current) | 6 | 6 |
| Panic Disorder (Lifetime) | 11 | 10 |
| Agoraphobia (Current) | 7 | 9 |
| Social Anxiety Disorder (Current) | 6 | 9 |
| Obsessive Compulsive Disorder (Current) | 3 | 3 |
| Post Traumatic Stress Disorder (Current) | 9 | 12 |
| Alcohol Use Disorder (Past 12 months) | 13 | 8 |
| Substance Use Disorder (Past 12 months) | 11 | 8 |
| Any Psychotic Disorder (Current) | 0 | 0 |
| Any Psychotic Disorder (Lifetime) | 0 | 1 |
| Major Depressive Disorder with Psychotic Features (Current) | 0 | 0 |
| Major Depressive Disorder with Psychotic Features (Past) | 0 | 0 |
| Anorexia Nervosa (current) | 0 | 1 |
| Bulimia Nervosa (Current) | 4 | 4 |
| Binge Eating Disorder (Current) | 2 | 4 |
| Generalized Anxiety Disorder (Current) | 10 | 15 |
| Antisocial Personality Disorder (Lifetime) | 8 | 4 |
| ADHD Combined Type (Current) | 2 | 4 |
| ADHD Inattentive Type (Current) | 0 | 1 |
| ADHD Hyperactive Type (Current) | 1 | 1 |
| Tourette's Syndrome (Lifetime) | 0 | 1 |
| Persistent Motor Tic Disorder (Lifetime) | 1 | 1 |
| Provisional Vocal Tic Disorder (Lifetime) | 0 | 0 |
| Provisional Tic Disorder (Lifetime) | 0 | 0 |
| Specific Phobia | 4 | 1 |
| Body Dysmorphic Disorder (Current) | 3 | 2 |
Subjects will complete the SDS at all visits. The change in scores from baseline to study completion will be assessed. The scale itself assesses the level of disability from borderline personality disorder (or target disorder) with higher scores indicating a more debilitating disorder. Scores range from 0-30.
| score on a scale | Placebo | Rexulti |
|---|---|---|
| Visit 1 | 17.3 (0 to 30) | 15.8 (0 to 30) |
| Visit 2 | 13.3 (0 to 30) | 10.7 (0 to 30) |
| Visit 3 | 11.5 (0 to 30) | 7.8 (0 to 30) |
| Visit 4 | 12.4 (0 to 30) | 7.8 (0 to 30) |
| Visit 5 | 11.7 (0 to 30) | 7.0 (0 to 30) |
| Visit 6 | 11.2 (0 to 30) | 7.9 (0 to 30) |
| Visit 7 | 12.0 (0 to 30) | 6.9 (0 to 30) |
| Visit 8 | 12.7 (0 to 30) | 7.7 (0 to 30) |
A self-report assessment of patient perceived quality of life that will be assessed at baseline and visit 8. Higher scores indicate a higher quality of life, whereas lower scores indicate a lower quality of life. Participants are asked to rate the importance of each domain on a 3-point scale ranging from 1=not important to 3=very important, and to rate how satisfied they are with that domain on a 6-point scale, ranging from -3=very dissatisfied to +3=very satisfied. In scoring, importance ratings are multiplied by satisfaction ratings to produce weighted satisfaction scores for each of the 16 domains. Weighted satisfaction scores are summed and divided by the number of domains that were rated as important or very important to produce a raw score, which is then converted to a t-score, which provides a proxy measurement for perceived quality of life. T-scores range from very low perceived quality of life (0-36) to high perceived quality of life (58-77).
| score on a scale | Placebo | Rexulti |
|---|---|---|
| Visit 1 | 28.89 ± 9.11 | 28.70 ± 11.18 |
| Visit 8 | 30.75 ± 10.62 | 35.71 ± 6.43 |
A self-report scale measuring suicidality. Subjects will complete the scale at all visits. Subjects are asked about suicidal thoughts. If answers are no, rater can proceed to "suicidal behavior" section where subject is asked about any non-suicidal self injurious behavior. If yes, subject is asked about intensity of ideations. In the event of serious threat to themselves, the subject will be escorted to the emergency room. Total score indicates severity of suicidal ideation and behavior, with lower scores representing lower levels of suicidality and higher scores representing higher levels of suicidality. A score of 0 would reflect no suicidality present, whereas a maximum score of 5 would reflect active suicidal ideation with intent to act.
| score on a scale | Placebo | Rexulti |
|---|---|---|
| Visit 1 | 1.15 ± 1.72 | 0.73 ± 0.99 |
| Visit 8 | 0.23 ± 0.66 | 0.08 ± 0.35 |
Collected over Through study completion, an average of 12 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/40 (0%) | 1/40 (2.5%) | 19/40 (47.5%) |
| Rexulti | 0/40 (0%) | 0/40 (0%) | 11/40 (27.5%) |
| Event | Placebo | Rexulti |
|---|---|---|
| Suicidal IdeationPsychiatric disorders | 1/40 | 0/40 |
| Event | Placebo | Rexulti |
|---|---|---|
| NauseaGastrointestinal disorders | 6/40 | 2/40 |
| FatigueGeneral disorders | 4/40 | 2/40 |
| RestlessnessGeneral disorders | 3/40 | 3/40 |
| Dry MouthGeneral disorders | 0/40 | 3/40 |
| HeadacheGeneral disorders | 2/40 | 1/40 |
| HallucinationsPsychiatric disorders | 2/40 | 0/40 |
| Sleep ProblemsGeneral disorders | 2/40 | 0/40 |
| TremorGeneral disorders | 1/40 | 0/40 |
| SweatingGeneral disorders | 1/40 | 0/40 |
| Increase AppetiteGeneral disorders | 1/40 | 1/40 |
Adults aged 18-65 years with a primary diagnosis of BPD and a Zanarini-BPD scale score of at least 9 at study entry who completed all baseline measures.
| Age, Continuous(years) | Placebo | Rexulti | Total |
|---|---|---|---|
| Mean | 28.9 (19 to 54) | 30.9 (19 to 61) | 29.9 (19 to 61) |
| Sex/Gender, Customized(Participants) | Placebo | Rexulti | Total |
|---|---|---|---|
| Female | 21 | 24 | 45 |
| Male | 12 | 9 | 21 |
| Other | 4 | 2 | 6 |
| Unknown/Not reported | 0 | 5 | 5 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | Rexulti | Total |
|---|---|---|---|
| Hispanic or Latino | 8 | 7 | 15 |
| Not Hispanic or Latino | 13 | 19 | 32 |
| Unknown or Not Reported | 16 | 14 | 30 |
| Race (NIH/OMB)(Participants) | Placebo | Rexulti | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 6 | 7 | 13 |
| White | 22 | 20 | 42 |
| More than one race | 1 | 2 | 3 |
| Unknown or Not Reported | 6 | 9 | 15 |
| Education(Participants) | Placebo | Rexulti | Total |
|---|---|---|---|
| Less than HS diploma/GED | 0 | 0 | 0 |
| HS diploma/GED | 5 | 7 | 12 |
| Some college/Associates | 20 | 18 | 38 |
| Bachelors | 11 | 9 | 20 |
| Masters+ | 0 | 3 | 3 |
| Unknown/ Not Reported | 1 | 3 | 4 |
| Employment Status(Participants) | Placebo | Rexulti | Total |
|---|---|---|---|
| Full-time | 11 | 12 | 23 |
| Part-time | 2 | 3 | 5 |
| Student | 8 | 8 | 16 |
| Unemployed | 15 | 11 | 26 |
| Retired | 0 | 0 | 0 |
| Other | 1 | 1 | 2 |
| Unknown/Not Reported | 0 | 5 | 5 |
| Marital Status(Participants) | Placebo | Rexulti | Total |
|---|---|---|---|
| Single | 31 | 27 | 58 |
| Married | 2 | 3 | 5 |
| Divorced/separated | 3 | 6 | 9 |
| Living together/engaged | 1 | 1 | 2 |
| Widowed | 0 | 0 | 0 |
| Unknown/Not reported | 0 | 3 | 3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Nov 2018 to primary completion in Dec 2020, 25 months.
Results were first posted in Mar 2022, 1 year 2 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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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: Brexpiprazole
Borderline Personality Disorder →