A Phase 2 interventional study of Ketamine and Midazolam in Borderline Personality Disorder, sponsored by Yale University. Terminated at 2 sites in United States. Open to participants aged 21 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-06-26.
Sponsored by Yale University · 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 50th largest by enrollment of the 71 interventional ones, is one of 2 that started in 2018, is one of 16 in phase 2, and was the 42nd registered.
278 studies on the registry are indexed under Borderline Personality Disorder; 70 are open to participants now.
This study's enrollment of 22 is below the median of 70 across 221 interventional studies indexed under Borderline Personality Disorder.
Browse Borderline Personality Disorder studies →15 of the 81 studies in Borderline Personality Disorder with a site in United States are open now, in 1 country. Each count lists the studies.
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: 21 Years to 60 Years · all sexes · no healthy volunteers.
The full table on the hub →81 studies; the count open now beside each. This study's row is marked.
First in 1997; this study’s year is marked. 2 started in 2018.
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.
9 of 81 have an industry lead sponsor. The 10 most frequent:
Yale University is the lead sponsor of 1,770 studies on the registry; 294 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.
Yale University has 5 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 |
Among the 81 studies in Borderline Personality Disorder with a site in United States, from their registry updates:
The purpose of this study is to test the potential of the rapid-acting anti-depressant ketamine to decrease suicidality in Borderline Personality Disorder (BPD).
The rate of completed suicide in BPD is similar to that of depression or schizophrenia. There is currently no specific medication treatment for BPD.
Ketamine is an FDA-approved anesthetic agent that has been shown to rapidly decrease suicidality and improve mood in people with Major Depressive Disorder (MDD). Though symptoms overlap, effective treatments for MDD and BPD differ. This clinical trial tests if ketamine also decreases suicidality and improves mood in BPD.
This trial will also measure several other outcomes after ketamine versus placebo in BPD: adverse events, BPD symptoms, pain, social cognition, and neuroplasticity.
This clinical trial primarily tests the impact of ketamine on suicidal thoughts in Borderline Personality Disorder (BPD). It also tests the impact of ketamine on symptom intensity (for mood, BPD, and pain symptoms), social cognition, and neuroplasticity in people with BPD.
Suicidal ideation and action are too common in BPD, occurring at rates similar to those in people with depression or schizophrenia. Intensive psychotherapy helps, but many people with BPD do not have access to that treatment, and not everyone responds to psychotherapy if they do get access. No medication is FDA-approved for BPD, and no medication has been shown to decrease suicidality in BPD.
Ketamine is a promising medication for this problem. It is an FDA-approved anesthetic medication with N-methyl D-aspartate activity. Sub-anesthetic doses of ketamine decrease suicidality and improve mood in people with Major Depressive Disorder (MDD). This effect is rapid, with symptom improvement within hours that endures approximately two weeks. People with BPD can have symptoms that overlap with those of MDD, however, the effective treatments for BPD and MDD differ. This clinical trial will test if ketamine, which is effective in MDD, is also effective in BPD.
The investigators will use semi-structured interviews and self-report questionnaires to measure suicidal ideation and clinical symptoms (adverse events, mood symptoms, BPD symptoms, and pain). Social cognition will be also be measured using both interviews/questionnaires and cognitive psychology tasks.
One proposed mechanism of ketamine's effect in MDD is increased neuroplasticity - opening a window during which new learning can occur. This mechanism has been demonstrated in rodent models of depression. In BPD, negatively-biased social interpretations impede meaningful recovery and increase suicide risk over time. A post-ketamine neuro-plastic window may provide an opportunity for revisions of rigid social attributions. The investigators will test for changes in neuroplasticity using a cognitive psychology task and electro-encephalography.
Baseline measures of demographics, life experiences, and symptoms may also be used to predict outcomes or as co-variates in our analyses.
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Midazolam IV; 0.04mg/kg over 40 minutes
Drug: Midazolam
ketamine IV; 0.5 mg/kg over 40 minutes
Drug: Ketamine
1 single dose of IV ketamine
1 single dose of IV midazolam
Change in Suicidal Thoughts as Measured by Item 10 on the Montgomery-Asberg Depression Scale (MADRS)
The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. Scores are averaged across items and can range from 0 to 6 (with 0 indicating enjoying life, and 6 indicating explicit plans for suicide). Outcome description updated when results were entered.
Time frame: Timepoints will be baseline, 1hr post-infusion and at 1, 3, 7, 14, & 28 days after infusion.
Change in Suicidality as Measured by the Columbia Suicide Severity Rating Scale (C-SSRS)
Suicide Rating Scale from 1-5; higher numbers indicate increased suicidal thinking.
Time frame: Timepoints will be baseline, 1hr post-infusion and at 1, 3, 7, 14, & 28 days after infusion.
Change in Suicidality as Measured by Item-12 on the Quick Inventory of Depressive Symptomatology (QIDS SR-16)
The Quick Inventory of Depressive Symptomatology (QIDS SR-16) is a a self-report measure of depression. Each item is scored from 0-3. Higher scores denote more severe load of depressive symptoms. Item 12 measures thoughts of death or suicide from 0 (no thoughts) to 3 (specific suicide plan or action.). Presented is the mean score across items with a range of 0 to 3 where the higher score indicates greater depressive symptoms. Outcome description was updated at the time of results entry.
Time frame: Timepoints will be baseline, 1hr post-infusion and at 1, 3, 7, 14, & 28 days after infusion.
Change in Suicidality as Measured by Item 9 on Beck Depression Inventory
When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is used to quantify the participant's degree of depression from 0 = no depression to 63 = maximally severe depression. Item 9 measures degree of suicidal thoughts or wishes from 0 = no thoughts to 3 = suicidal intent.
Time frame: Timepoints will be baseline, 1hr post-infusion and at 1, 3, 7, 14, & 28 days after infusion.
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
The MADRS scale measures the depression level of a participant. The total score was derived by adding the scores of the following 10 items: 1, Apparent sadness; 2, Reported sadness; 3, Inner tension; 4, Reduced sleep; 5, Reduced appetite; 6, Concentration difficulties; 7, Lassitude; 8, Inability to feel; 9, Pessimistic thoughts; 10, Suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The maximum total score is 60; 0, no depression; 60, severely depressed.
Time frame: Timepoints will be baseline, 1hr post-infusion and at 1, 3, 7, 14, & 28 days after infusion.
Change in Beck Depression Inventory Score
The Beck Depression Inventory (BDI) consisted of twenty-one questions about how the subject has been feeling in the last week. Each question has a set of at least four possible answer choices, ranging in intensity. When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is used to quantify the participant's degree of depression from 0 = no depression to 63 = maximally severe depression.
Time frame: Timepoints will be baseline, 1hr post-infusion and at 1, 3, 7, 14, & 28 days after infusion.
Change in Beck Anxiety Inventory Score
The Beck Anxiety Inventory (BDI) consisted of twenty-one questions about how the subject has been feeling in the last week. Each question has a set of at least four possible answer choices, ranging in intensity. When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is used to quantify the participant's degree of anxiety from 0 = no anxiety to 63 = maximally severe anxiety.
Time frame: Timepoints will be baseline, 1hr post-infusion and at 1, 3, 7, 14, & 28 days after infusion.
Change in Zanarini Rating Scale for Borderline Personality Disorder
A dimensional self-report measure of BPD symptoms that consists of 9 items scored on a 4 point likert scale. Scores range of 0 = minimally symptomatic to 28 = maximally symptomatic for symptoms of Borderline Personality Disorder. Originally, 1hr post-infusion was included as a time frame but this was not collected at this time frame.
Time frame: Timepoints will be baseline and at 1, 3, 7, 14, & 28 days after infusion.
Change in Preferred Distance in Stop-distance Paradigm (SDP)
The stop-distance paradigm is a measure of preferred interpersonal distance (PID). Subjects begin the task standing face-to-face and 6 feet away from a test confederate. On each of 3 trials, the confederate slowly approaches the subject. The subjects are instructed to say "stop" to indicate their 1) preferred conversational distance, then a closer distance 2) "if you start to feel uncomfortable". After each "stop", toe to toe distance is measured using a tape measure, and mean PID for the three trials is computed separately for conversational and uncomfortable distance. A computerized version of the task may also be implemented for remote visits and administered in place of the in-person task.
Time frame: Timepoints will be at baseline and 3, 7, 14, 28 days after infusion
Change in Behavior in the Economic Trust Game - Cooperation
The trust game is a multi-round economic exchange game. There are two roles in the game: investor and trustee. Study participants will play as the trustee. Each round, the investor is given a set number of points and can send any amount to the trustee. The investment triples and the trustee decides how much to repay the investor. Outcome measures are cooperation (amount returned to the investor) and coaxing (amount returned to investor on trials when poor prior returns from trustee have led investor to decrease investment). Cooperation was used as part of the evaluation in this study- coaxing was not. Outcome measure description was updated at the time of results entry.
Time frame: Timepoints will be at baseline and 3, 7, 14, 28 days after infusion
Change in Social Adjustment Scale Self Report (SAS-SR) Short Version Score
This questionaire measures expressive and instrumental performance over the past two weeks in six role areas: (1) work, either as a paid worker, unpaid homemaker, or student, (2) social and leisure activities, (3) relationships with extended family, (4) role as a marital partner, (5) parental role, and (6) role within the family unit, including perceptions about economic functioning.Each question is rated on a five-point scale from which role area means and an overall mean can be obtained, with higher scores denoting greater impairment. Role areas not relevant to the respondent can be skipped. Overall means are based on all items completed by the respondent. Scores range from 0 = no difficulties to 125 = broad difficulties in multiple domains. An overall adjustment
Time frame: Timepoints will be at baseline and 3, 7, 14, 28 days after infusion
Change in Brief Pain Inventory Score - Intensity
Self report inventory that assesses intensity of pain and its interference with everyday life. Intensity: pain severity as measured by a 0 to 10 visual analogue scale. 0 = no pain, 10 = worst pain imaginable. Interference score: Interference as measured by a 0 to 10 numerical rating scale. 0 = does not interfere, 10 = completely interferes
Time frame: Timepoints will be at baseline, and post-infusion 1hr, and days 1, 3, 7, 14, & 28.
Change in Brief Pain Inventory Score - Interference
Self report inventory that assesses intensity of pain and its interference with everyday life. Intensity: pain severity as measured by a 0 to 10 visual analogue scale. 0 = no pain, 10 = worst pain imaginable. Interference score: Interference as measured by a 0 to 10 numerical rating scale. 0 = does not interfere, 10 = completely interferes
Time frame: Timepoints will be at baseline, and post-infusion 1hr, and days 1, 3, 7, 14, & 28.
Change in Clinician-Administered Dissociative States Scale (CADSS) Score
This scale captures the range of possible subjective side effects of ketamine or Midazolam. This consists of 23 questions and scores for each question range from 0-4. The maximum score is 92 with higher scores indicating more dissociative symptoms.
Time frame: Timepoints: pre- infusion, during infusion +20, +40 minutes, and post-infusion 40 minutes.
Change in Adverse Events
Adverse events were tracked in a log of treatment emergent adverse events, EKG, pulse oximetry, vital signs. A count of any treatment emergent adverse events is presented through Day 28. The outcome measure description as updated when results were entered.
Time frame: Timepoints: Continuous monitoring throughout infusion; post-infusion days 1, 3, 7, 14, 28.
Change in 'Reading the Mind in the Eyes' Test (RMET) Score
The RMET is an advanced test of theory of mind. It is widely used to assess individual differences in social cognition and emotion recognition across different groups and cultures. This is a score from 0-36 where higher score indicates better performance.
Time frame: Timepoints: at baseline and 3, 7, 14, 28 days after infusion.
Change in Brief Psychiatric Rating Scale (BPRS) Total Scores
BPRS is an 18-item clinician rated scale with 11 general symptom items, 5 positive-symptom items, and 2 negative symptom items scored on a 7-point scale (1=not present and 7=extremely severe), with higher score indicating greater severity of symptom. Total possible score range=18 to 126.
Time frame: Timepoints: pre-infusion, during infusion +20, +40 minutes, post-infusion +40 minutes
Change in Beck Suicide Scale Total Score
The Beck Suicide Scale is a 23 item self report scale with items to specifically assess the presence and intensity of thoughts and actions related to suicidality. Each item response is on a 3 point likert (0-2) for each of 21 items, so possible totals range from 0-42. Higher scores indicate higher suicidality. The description was updated when results were entered.
Time frame: Timepoints will be baseline, 1hr post-infusion and at 1, 3, 7, 14, & 28 days after infusion.
Change in Bias Scores on the Implicit Association Tests (IAT) of Death, Escape and Self Harm Imagery.
The Implicit Association Test measures implicit automatic associations by tracking the speed at which participants associate different groups of words. The scale is delivered electronically using an open-source software. Three distinct IATs will be administered to assess participant's implicit associations with death, escape, and self harm imagery respectively.
Time frame: Timepoints: at baseline and 1, 3, 7, 28 days after infusion.
Change in Resting State Electroencephalography (EEG)
measurement of electrical patterns in the brain while subject is at rest with eyes open looking at fixation cross
Time frame: Timepoints: at baseline and 1 and/or 7 days after infusion.
Change in Electroencephalography (EEG) Signal During Behavioral Neuroplasticity Task
measurement of electrical patterns in the brain while subject is performing behavioral task to measure basic neuroplasticity
Time frame: Timepoints: at baseline and 1 and/or 7 days after infusion.
| Milestone | Midazolam | Low Dose Ketamine |
|---|---|---|
| Started | 12 | 10 |
| Completed | 12 | 10 |
| Not completed | 0 | 0 |
The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. Scores are averaged across items and can range from 0 to 6 (with 0 indicating enjoying life, and 6 indicating explicit plans for suicide). Outcome description updated when results were entered.
| units on a scale | Midazolam | Low Dose Ketamine |
|---|---|---|
| baseline | 2.66 ± 0.37 | 2.7 ± 0.41 |
| 1hr post-infusion | 0.0 ± 0.37 | 0.1 ± 0.41 |
| Day 1 post-infusion | 0.59 ± 0.38 | 0.5 ± 0.41 |
| Day 3 post-infusion | 0.89 ± 0.38 | 0.7 ± 0.41 |
| Day 7 post-infusion | 0.83 ± 0.37 | 0.8 ± 0.41 |
| Day 14 post-infusion | 1.66 ± 0.37 | 1.3 ± 0.41 |
| Day 28 post-infusion | 1.29 ± 0.4 | 2.6 ± 0.42 |
Suicide Rating Scale from 1-5; higher numbers indicate increased suicidal thinking.
| score on a scale | Midazolam | Low Dose Ketamine |
|---|---|---|
| baseline | 1.58 ± 0.31 | 1.9 ± 0.34 |
| 1hr post-infusion | 0 ± 0.31 | 0.0 ± 0.34 |
| Day 1 post-infusion | 0 ± 0.31 | 0.0 ± 0.34 |
| Day 3 post-infusion | 0.75 ± 0.31 | 0.5 ± 0.34 |
| Day 7 post-infusion | 0.83 ± 0.31 | 0.3 ± 0.34 |
| Day 14 post-infusion | 0.91 ± 0.31 | 0.8 ± 0.34 |
| Day 28 post-infusion | 1.16 ± 0.31 | 1.6 ± 0.34 |
The Quick Inventory of Depressive Symptomatology (QIDS SR-16) is a a self-report measure of depression. Each item is scored from 0-3. Higher scores denote more severe load of depressive symptoms. Item 12 measures thoughts of death or suicide from 0 (no thoughts) to 3 (specific suicide plan or action.). Presented is the mean score across items with a range of 0 to 3 where the higher score indicates greater depressive symptoms. Outcome description was updated at the time of results entry.
| score on a scale | Midazolam | Low Dose Ketamine |
|---|---|---|
| baseline | 1.25 ± 0.21 | 1.5 ± 0.23 |
| 1hr post-infusion | 0.08 ± 0.21 | 0.2 ± 0.23 |
| Day 1 post-infusion | 0.34 ± 0.21 | 0.1 ± 0.23 |
| Day 3 post-infusion | 0.33 ± 0.21 | 0.3 ± 0.23 |
| Day 7 post-infusion | 0.34 ± 0.21 | 0.5 ± 0.23 |
| Day 14 post-infusion | 0.71 ± 0.21 | 0.7 ± 0.23 |
| Day 28 post-infusion | 0.55 ± 0.22 | 1.21 ± 0.23 |
When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is used to quantify the participant's degree of depression from 0 = no depression to 63 = maximally severe depression. Item 9 measures degree of suicidal thoughts or wishes from 0 = no thoughts to 3 = suicidal intent.
| units on a scale | Midazolam | Low Dose Ketamine |
|---|---|---|
| baseline | 1.16 ± 0.19 | 1.2 ± 0.21 |
| 1hr post-infusion | 0.08 ± 0.19 | 0.1 ± 0.21 |
| Day 1 post-infusion | 0.36 ± 0.19 | 0.3 ± 0.21 |
| Day 3 post-infusion | 0.24 ± 0.19 | 0.3 ± 0.21 |
| Day 7 post-infusion | 0.41 ± 0.19 | 0.3 ± 0.21 |
| Day 14 post-infusion | 0.5 ± 0.19 | 0.3 ± 0.21 |
| Day 28 post-infusion | 0.70 ± 0.19 | 0.56 ± 0.21 |
The MADRS scale measures the depression level of a participant. The total score was derived by adding the scores of the following 10 items: 1, Apparent sadness; 2, Reported sadness; 3, Inner tension; 4, Reduced sleep; 5, Reduced appetite; 6, Concentration difficulties; 7, Lassitude; 8, Inability to feel; 9, Pessimistic thoughts; 10, Suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The maximum total score is 60; 0, no depression; 60, severely depressed.
| score on a scale | Midazolam | Low Dose Ketamine |
|---|---|---|
| Baseline | 26.75 ± 2.71 | 28.3 ± 2.97 |
| 1hr post-infusion | 3.66 ± 2.71 | 6.2 ± 2.97 |
| Day 1 | 9.27 ± 2.78 | 8.2 ± 2.97 |
| Day 3 | 11.70 ± 2.78 | 12.2 ± 2.97 |
| Day 7 | 12.5 ± 2.71 | 12.3 ± 2.97 |
| Day 14 | 19.25 ± 2.71 | 12.9 ± 2.97 |
| Day 28 | 17.39 ± 2.85 | 22.67 ± 3.06 |
The Beck Depression Inventory (BDI) consisted of twenty-one questions about how the subject has been feeling in the last week. Each question has a set of at least four possible answer choices, ranging in intensity. When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is used to quantify the participant's degree of depression from 0 = no depression to 63 = maximally severe depression.
| score on a scale | Midazolam | Low Dose Ketamine |
|---|---|---|
| Baseline | 30.75 ± 3.96 | 34.9 ± 4.34 |
| 1hr post-infusion | 11.16 ± 3.96 | 13.3 ± 4.34 |
| Day 1 | 12.41 ± 4.04 | 12.2 ± 4.34 |
| Day 3 | 10.94 ± 4.04 | 8.9 ± 4.34 |
| Day 7 | 11.33 ± 3.96 | 12.6 ± 4.34 |
| Day 14 | 17.41 ± 3.96 | 14.5 ± 4.34 |
| Day 28 | 17.57 ± 4.04 | 18.73 ± 4.44 |
The Beck Anxiety Inventory (BDI) consisted of twenty-one questions about how the subject has been feeling in the last week. Each question has a set of at least four possible answer choices, ranging in intensity. When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is used to quantify the participant's degree of anxiety from 0 = no anxiety to 63 = maximally severe anxiety.
| score on a scale | Midazolam | Low Dose Ketamine |
|---|---|---|
| Baseline | 21.75 ± 2.51 | 21.7 ± 2.75 |
| 1hr post-infusion | 4.0 ± 2.51 | 7.3 ± 2.75 |
| Day 1 | 7.43 ± 2.57 | 8.3 ± 2.75 |
| Day 3 | 5.71 ± 2.71 | 5.5 ± 2.75 |
| Day 7 | 7.43 ± 2.57 | 8.2 ± 2.75 |
| Day 14 | 8.88 ± 2.57 | 11.0 ± 2.75 |
| Day 28 | 6.34 ± 2.65 | 18.23 ± 2.91 |
A dimensional self-report measure of BPD symptoms that consists of 9 items scored on a 4 point likert scale. Scores range of 0 = minimally symptomatic to 28 = maximally symptomatic for symptoms of Borderline Personality Disorder. Originally, 1hr post-infusion was included as a time frame but this was not collected at this time frame.
| score on a scale | Midazolam | Low Dose Ketamine |
|---|---|---|
| Baseline | 14.33 ± 1.78 | 15.4 ± 1.95 |
| Day 1 | 3.52 ± 1.81 | 5.2 ± 1.95 |
| Day 3 | 5.04 ± 1.81 | 5.2 ± 1.95 |
| Day 7 | 5 ± 1.78 | 6.8 ± 1.95 |
| Day 14 | 6.75 ± 1.78 | 7.2 ± 1.95 |
| Day 28 | 7.16 ± 1.81 | 11.42 ± 1.99 |
The stop-distance paradigm is a measure of preferred interpersonal distance (PID). Subjects begin the task standing face-to-face and 6 feet away from a test confederate. On each of 3 trials, the confederate slowly approaches the subject. The subjects are instructed to say "stop" to indicate their 1) preferred conversational distance, then a closer distance 2) "if you start to feel uncomfortable". After each "stop", toe to toe distance is measured using a tape measure, and mean PID for the three trials is computed separately for conversational and uncomfortable distance. A computerized version of the task may also be implemented for remote visits and administered in place of the in-person task.
| distance in inches | Midazolam | Low Dose Ketamine |
|---|---|---|
| Baseline | 18.6 ± 1.97 | 20.6 ± 2.5 |
| Day 3 | 17.3 ± 2.12 | 17.2 ± 2.5 |
| Day 7 | 14.7 ± 2.11 | 15.5 ± 2.5 |
| Day 14 | 19.4 ± 1.97 | 16.5 ± 2.5 |
| Day 28 | 17.2 ± 2.11 | 19.5 ± 2.63 |
The trust game is a multi-round economic exchange game. There are two roles in the game: investor and trustee. Study participants will play as the trustee. Each round, the investor is given a set number of points and can send any amount to the trustee. The investment triples and the trustee decides how much to repay the investor. Outcome measures are cooperation (amount returned to the investor) and coaxing (amount returned to investor on trials when poor prior returns from trustee have led investor to decrease investment). Cooperation was used as part of the evaluation in this study- coaxing was not. Outcome measure description was updated at the time of results entry.
| proportion of amount returned | Midazolam | Low Dose Ketamine |
|---|---|---|
| Baseline | 0.39 ± 0.05 | 0.38 ± 0.06 |
| Day 3 | 0.36 ± 0.05 | 0.42 ± 0.06 |
| Day 7 | 0.42 ± 0.05 | 0.29 ± 0.06 |
| Day 14 | 0.34 ± 0.05 | 0.39 ± 0.06 |
| Day 28 | 0.31 ± 0.09 | 0.31 ± 0.06 |
This questionaire measures expressive and instrumental performance over the past two weeks in six role areas: (1) work, either as a paid worker, unpaid homemaker, or student, (2) social and leisure activities, (3) relationships with extended family, (4) role as a marital partner, (5) parental role, and (6) role within the family unit, including perceptions about economic functioning.Each question is rated on a five-point scale from which role area means and an overall mean can be obtained, with higher scores denoting greater impairment. Role areas not relevant to the respondent can be skipped. Overall means are based on all items completed by the respondent. Scores range from 0 = no difficulties to 125 = broad difficulties in multiple domains. An overall adjustment
| score on a scale | Midazolam | Low Dose Ketamine |
|---|---|---|
| Baseline | 2.86 ± 0.18 | 2.74 ± 0.20 |
| Day 3 | 2.30 ± 0.19 | 1.95 ± 0.20 |
| Day 7 | 2.17 ± 0.19 | 2.02 ± 0.20 |
| Day 14 | 2.58 ± 0.18 | 2.07 ± 0.20 |
| Day 28 | 2.33 ± 0.19 | 2.12 ± 0.20 |
Self report inventory that assesses intensity of pain and its interference with everyday life. Intensity: pain severity as measured by a 0 to 10 visual analogue scale. 0 = no pain, 10 = worst pain imaginable. Interference score: Interference as measured by a 0 to 10 numerical rating scale. 0 = does not interfere, 10 = completely interferes
| score on a scale | Midazolam | Low Dose Ketamine |
|---|---|---|
| Baseline | 6.19 ± 0.93 | 6.32 ± 1.03 |
| Post-infusion 1hr | 5.75 ± 1.64 | 2.56 ± 2.23 |
| Day 1 | 6.52 ± 1.34 | 4.46 ± 2.28 |
| Day 3 | 6.73 ± 1.61 | 4.46 ± 2.28 |
| Day 7 | 9.04 ± 2.22 | 5.92 ± 1.16 |
| Day 14 | 3.2 ± 1.33 | 4.14 ± 1.16 |
| Day 28 | 6.28 ± 1.62 | 5.11 ± 1.33 |
Self report inventory that assesses intensity of pain and its interference with everyday life. Intensity: pain severity as measured by a 0 to 10 visual analogue scale. 0 = no pain, 10 = worst pain imaginable. Interference score: Interference as measured by a 0 to 10 numerical rating scale. 0 = does not interfere, 10 = completely interferes
| score on a scale | Midazolam | Low Dose Ketamine |
|---|---|---|
| Baseline | 3.49 ± 1.05 | 2.94 ± 1.13 |
| Post-infusion 1hr | 1.22 ± 1.58 | 0.51 ± 1.94 |
| Day 1 | 4.79 ± 1.34 | 3.1 ± 2.03 |
| Day 3 | 3.41 ± 1.51 | 3.1 ± 2.03 |
| Day 7 | 4.06 ± 1.95 | 4.09 ± 1.36 |
| Day 14 | 2.21 ± 1.36 | 3.45 ± 1.19 |
| Day 28 | 4.23 ± 1.64 | 4.52 ± 1.36 |
This scale captures the range of possible subjective side effects of ketamine or Midazolam. This consists of 23 questions and scores for each question range from 0-4. The maximum score is 92 with higher scores indicating more dissociative symptoms.
| score on a scale | Midazolam | Low Dose Ketamine |
|---|---|---|
| Baseline (pre-infusion) | 5.94 ± 4.11 | 5.92 ± 3.99 |
| 20 minutes (during infusion) | 5.54 ± 3.46 | 25.4 ± 3.63 |
| 40 minutes (during infusion) | 9.54 ± 3.46 | 16.8 ± 3.63 |
| 80 minutes (post infusion) | 1.90 ± 3.46 | 3.0 ± 3.63 |
Adverse events were tracked in a log of treatment emergent adverse events, EKG, pulse oximetry, vital signs. A count of any treatment emergent adverse events is presented through Day 28. The outcome measure description as updated when results were entered.
| Participants | Midazolam | Low Dose Ketamine |
|---|---|---|
| Change in Adverse Events | 0 | 0 |
The RMET is an advanced test of theory of mind. It is widely used to assess individual differences in social cognition and emotion recognition across different groups and cultures. This is a score from 0-36 where higher score indicates better performance.
| score on a scale | Midazolam | Low Dose Ketamine |
|---|---|---|
| Baseline | 28.2 ± 1.11 | 25.6 ± 1.23 |
| Day 3 | 27.6 ± 1.13 | 27.3 ± 1.23 |
| Day 7 | 29.2 ± 1.11 | 26.6 ± 1.23 |
| Day 14 | 29.9 ± 1.11 | 25.1 ± 1.23 |
| Day 28 | 29.9 ± 1.11 | 25.4 ± 1.26 |
BPRS is an 18-item clinician rated scale with 11 general symptom items, 5 positive-symptom items, and 2 negative symptom items scored on a 7-point scale (1=not present and 7=extremely severe), with higher score indicating greater severity of symptom. Total possible score range=18 to 126.
| score on a scale | Midazolam | Low Dose Ketamine |
|---|---|---|
| Baseline (pre-infusion) | 29.36 ± 2.34 | 33.79 ± 2.20 |
| 20 Minutes (during infusion) | 28.18 ± 1.81 | 38.7 ± 1.90 |
| 40 Minutes (during infusion) | 28.0 ± 1.81 | 36.2 ± 1.90 |
| 80 Minutes (post infusion) | 25.9 ± 1.81 | 28.2 ± 1.90 |
The Beck Suicide Scale is a 23 item self report scale with items to specifically assess the presence and intensity of thoughts and actions related to suicidality. Each item response is on a 3 point likert (0-2) for each of 21 items, so possible totals range from 0-42. Higher scores indicate higher suicidality. The description was updated when results were entered.
| score on a scale | Midazolam | Low Dose Ketamine |
|---|---|---|
| Baseline | 7.66 ± 1.75 | 11.5 ± 1.91 |
| 1hr post-infusion | 3.5 ± 1.75 | 4.1 ± 1.91 |
| Day 1 | 3.13 ± 1.79 | 3.3 ± 1.91 |
| Day 3 | 2.92 ± 1.79 | 3.9 ± 1.91 |
| Day 7 | 3.08 ± 1.75 | 4.6 ± 1.91 |
| Day 14 | 5.66 ± 1.75 | 5.4 ± 1.91 |
| Day 28 | 4.51 ± 1.79 | 7.12 ± 1.97 |
The Implicit Association Test measures implicit automatic associations by tracking the speed at which participants associate different groups of words. The scale is delivered electronically using an open-source software. Three distinct IATs will be administered to assess participant's implicit associations with death, escape, and self harm imagery respectively.
Results for this outcome have not been posted.
measurement of electrical patterns in the brain while subject is at rest with eyes open looking at fixation cross
Results for this outcome have not been posted.
measurement of electrical patterns in the brain while subject is performing behavioral task to measure basic neuroplasticity
Results for this outcome have not been posted.
Collected over Uo to 28 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Midazolam | 0/12 (0%) | 0/12 (0%) | 7/12 (58.3%) |
| Low Dose Ketamine | 0/10 (0%) | 0/10 (0%) | 6/10 (60%) |
| Event | Midazolam | Low Dose Ketamine |
|---|---|---|
| Vivid dreamsNervous system disorders | 7/12 | 6/10 |
| Nausea or vomitingGastrointestinal disorders | 3/12 | 4/10 |
| HeadachesNervous system disorders | 4/12 | 1/10 |
| Fatigue/UnsteadinessNervous system disorders | 4/12 | 2/10 |
| Blurry/double visionNervous system disorders | 2/12 | 3/10 |
| Jerky muscle movementsMusculoskeletal and connective tissue disorders | 1/12 | 3/10 |
| DiarrheaGastrointestinal disorders | 2/12 | 1/10 |
| Hallucinations/MisperceptionsNervous system disorders | 0/12 | 1/10 |
| Increased thirstEndocrine disorders | 0/12 | 1/10 |
| Body painNervous system disorders | 0/12 | 1/10 |
| Age, Continuous(years) | Midazolam | Low Dose Ketamine | Total |
|---|---|---|---|
| Mean | 35.1 ± 11.4 | 32.1 ± 10.4 | 33.7 ± 10.8 |
| Sex: Female, Male(Participants) | Midazolam | Low Dose Ketamine | Total |
|---|---|---|---|
| Female | 10 | 8 | 18 |
| Male | 2 | 2 | 4 |
| Race/Ethnicity, Customized(Participants) | Midazolam | Low Dose Ketamine | Total |
|---|---|---|---|
| Asian | 1 | 0 | 1 |
| Arabic | 0 | 1 | 1 |
| White | 10 | 9 | 19 |
| Hispanic | 1 | 0 | 1 |
| Region of Enrollment(participants) | Midazolam | Low Dose Ketamine | Total |
|---|---|---|---|
| United States | 12 | 10 | 22 |
| Education (years)(years) | Midazolam | Low Dose Ketamine | Total |
|---|---|---|---|
| Mean | 16.3 ± 2.7 | 15.0 ± 2.7 | 15.7 ± 2.7 |
| Baseline Comorbidities(Participants) | Midazolam | Low Dose Ketamine | Total |
|---|---|---|---|
| Major Depressive Disorder | 5 | 5 | 10 |
| Post-Traumatic Stress Disorder | 4 | 3 | 7 |
| Anxiety Disorders | 9 | 7 | 16 |
| Mild Substance Use Disorder | 3 | 3 | 6 |
| Bipolar Disorder | 2 | 1 | 3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Feb 2018 to primary completion in May 2022, 50 months.
Results were first posted in Jun 2023, 1 year 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Ketamine
Borderline Personality Disorder →