Borderline Personality DisorderPhase 2NCT03395314
Ketamine in Borderline Personality Disorder
A Phase 2 study testing Ketamine and Midazolam in people with Borderline Personality Disorder, run by Yale University at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- Ketamine and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Feb 2018to 6 May 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 21-60
- Clinical diagnosis of Borderline Personality Disorder
- Has suicidal ideation.
- Fluent in English
- Has a current mental health treater, and agrees for study to communicate with treater
Who cannot join
- Current suicidal intent
- Med changes in last 4 weeks
- Any ketamine in any context in the last one year.
- Current prescription for topiramate, lamotrigine, or lithium.
- Psychotic disorder in self or first-degree relative
- Current substance dependence including alcohol dependence
Show all 12Show fewer
- Any history of NMDA (N-methyl-D-aspartate )-antagonist abuse
- Any history of opiate abuse
- History of major medical illness especially neurologic or cardiovascular condition, or any other medical contra-indication to ketamine administration at the discretion of the study MD.
- Positive urine test for drugs of abuse screening on day of ketamine administration
- Positive pregnancy test on day of ketamine administration
- At the discretion of study staff
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Connecticut Mental Health Center
New Haven, Connecticut, 06519
Yale New Haven Hospital
New Haven, Connecticut, 06519
About this study
Official title: A Randomized Active Placebo Controlled Trial of Ketamine in Borderline Personality Disorder
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Borderline Personality Disorder
- Keywords
- Borderline Personality Disorder, Ketamine, Suicide, Social Cognition
- Medical subject headings
- Borderline Personality Disorder, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| midazolam | Placebo comparator | Midazolam IV; 0.04mg/kg over 40 minutes Receives: Drug: Midazolam |
| low dose ketamine | Active comparator | ketamine IV; 0.5 mg/kg over 40 minutes Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Timepoints will be baseline, 1hr post-infusion and at 1, 3, 7, 14, & 28 days after infusion.
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Timepoints will be baseline, 1hr post-infusion and at 1, 3, 7, 14, & 28 days after infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study start15 Feb 2018
- Primary completion6 May 2022
- Study completion6 May 2022
Why it stopped: assessment of project in wake of covid-19 related interruptions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Nathan Kline Institute for Psychiatric Research, American Foundation for Suicide Prevention
- Responsible party
- Sponsor
- Investigators
- Sarah Fineberg, MD/PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03395314
- Sponsor's protocol ID
- 2000021457
- Status last verified
- May 2023
- First submitted
- 22 Dec 2017
- Last updated
- 26 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Active Placebo Controlled Trial of Ketamine in Borderline Personality Disorder
- ClinicalTrials.gov ID
- NCT03395314
- Acronym / sponsor ID
- 2000021457
- Conditions
- Borderline Personality Disorder
- Keywords
- Borderline Personality Disorder, Ketamine, Suicide, Social Cognition
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: assessment of project in wake of covid-19 related interruptions
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Nathan Kline Institute for Psychiatric Research, American Foundation for Suicide Prevention
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- 6 May 2022 (actual)
- Study completion
- 6 May 2022 (actual)
- First posted
- 10 Jan 2018 (actual)
- Results
- Posted 26 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| midazolam | Placebo comparator | Drug: MidazolamMidazolam IV; 0.04mg/kg over 40 minutes |
| low dose ketamine | Active comparator | Drug: Ketamineketamine IV; 0.5 mg/kg over 40 minutes |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 21-60
- Clinical diagnosis of Borderline Personality Disorder
- Has suicidal ideation.
- Fluent in English
- Has a current mental health treater, and agrees for study to communicate with treater
Key exclusion criteria (12 listed)
- Current suicidal intent
- Med changes in last 4 weeks
- Any ketamine in any context in the last one year.
- Current prescription for topiramate, lamotrigine, or lithium.
- Psychotic disorder in self or first-degree relative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketamine1 single dose of IV ketamine | Drug | low dose ketamine |
| Midazolam1 single dose of IV midazolam | Drug | midazolam |
Primary outcome
Change in Suicidal Thoughts as Measured by Item 10 on the Montgomery-Asberg Depression Scale (MADRS)
Time frame: Timepoints will be baseline, 1hr post-infusion and at 1, 3, 7, 14, & 28 days after infusion.
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.
Change in Suicidality as Measured by the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Timepoints will be baseline, 1hr post-infusion and at 1, 3, 7, 14, & 28 days after infusion.
Suicide Rating Scale from 1-5; higher numbers indicate increased suicidal thinking.
Change in Suicidality as Measured by Item-12 on the Quick Inventory of Depressive Symptomatology (QIDS SR-16)
Time frame: Timepoints will be baseline, 1hr post-infusion and at 1, 3, 7, 14, & 28 days after infusion.
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.
Change in Suicidality as Measured by Item 9 on Beck Depression Inventory
Time frame: Timepoints will be baseline, 1hr post-infusion and at 1, 3, 7, 14, & 28 days after infusion.
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.
14 secondary outcomes
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
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
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
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
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)
Time frame: Timepoints will be at baseline and 3, 7, 14, 28 days after infusion
Change in Behavior in the Economic Trust Game - Cooperation
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
Time frame: Timepoints will be at baseline and 3, 7, 14, 28 days after infusion
Change in Brief Pain Inventory Score - Intensity
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
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
Time frame: Timepoints: pre- infusion, during infusion +20, +40 minutes, and post-infusion 40 minutes.
Change in Adverse Events
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
Time frame: Timepoints: at baseline and 3, 7, 14, 28 days after infusion.
Change in Brief Psychiatric Rating Scale (BPRS) Total Scores
Time frame: Timepoints: pre-infusion, during infusion +20, +40 minutes, post-infusion +40 minutes
Change in Beck Suicide Scale Total Score
Time frame: Timepoints will be baseline, 1hr post-infusion and at 1, 3, 7, 14, & 28 days after infusion.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Fineberg, MD/PhD principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ketamine and Midazolam in people with Borderline Personality Disorder, run by Yale University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Suicidal Thoughts as Measured by Item 10 on the Montgomery-Asberg Depression Scale (MADRS) (time frame: Timepoints will be baseline, 1hr post-infusion and at 1, 3, 7, 14, & 28 days after infusion.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2023.