Trial · NCT03395314

Ketamine in Borderline Personality Disorder

NCT03395314, Phase 2, Terminated, Yale University; results first posted 2023-06-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Ketamine in Borderline Personality Disorder. Trials, record NCT03395314. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03395314

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Ketamine in Borderline Personality Disorder
NCT number: NCT03395314
Status: Terminated
Phases: Phase 2
Enrollment: 22 participants, actual
Lead sponsor: Yale University
Conditions: Borderline Personality Disorder
Interventions: Ketamine, Midazolam
First posted: 2018-01-10
Last updated: 2023-06-26
Results first posted: 2023-06-26

Source ClinicalTrials.gov

Registered outcomes21

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Suicidal Thoughts as Measured by Item 10 on the Montgomery-Asberg Depression Scale (MADRS)	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.
Primary	Change in Suicidality as Measured by the Columbia Suicide Severity Rating Scale (C-SSRS)	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.
Primary	Change in Suicidality as Measured by Item-12 on the Quick Inventory of Depressive Symptomatology (QIDS SR-16)	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.
Primary	Change in Suicidality as Measured by Item 9 on Beck Depression Inventory	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.
Secondary	Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score	Timepoints will be baseline, 1hr post-infusion and at 1, 3, 7, 14, & 28 days after infusion.	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.
Secondary	Change in Beck Depression Inventory Score	Timepoints will be baseline, 1hr post-infusion and at 1, 3, 7, 14, & 28 days after infusion.	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.
Secondary	Change in Beck Anxiety Inventory Score	Timepoints will be baseline, 1hr post-infusion and at 1, 3, 7, 14, & 28 days after infusion.	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.
Secondary	Change in Zanarini Rating Scale for Borderline Personality Disorder	Timepoints will be baseline and at 1, 3, 7, 14, & 28 days after infusion.	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.
Secondary	Change in Preferred Distance in Stop-distance Paradigm (SDP)	Timepoints will be at baseline and 3, 7, 14, 28 days after infusion	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.
Secondary	Change in Behavior in the Economic Trust Game - Cooperation	Timepoints will be at baseline and 3, 7, 14, 28 days after infusion	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.

1 to 10 of 21Source ClinicalTrials.gov

See all 21 registered outcomes

Outcomes21

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Suicidal Thoughts as Measured by Item 10 on the Montgomery-Asberg Depression Scale (MADRS)	Timepoints will be baseline, 1hr post-infusion and at 1, 3, 7, 14, & 28 days after infusion.	Intention to treat.	units on a scale	LEAST_SQUARES_MEAN
PRIMARY	Change in Suicidality as Measured by the Columbia Suicide Severity Rating Scale (C-SSRS)	Timepoints will be baseline, 1hr post-infusion and at 1, 3, 7, 14, & 28 days after infusion.	Intention to treat.	score on a scale	LEAST_SQUARES_MEAN
PRIMARY	Change in Suicidality as Measured by Item-12 on the Quick Inventory of Depressive Symptomatology (QIDS SR-16)	Timepoints will be baseline, 1hr post-infusion and at 1, 3, 7, 14, & 28 days after infusion.	Intention to treat.	score on a scale	LEAST_SQUARES_MEAN
PRIMARY	Change in Suicidality as Measured by Item 9 on Beck Depression Inventory	Timepoints will be baseline, 1hr post-infusion and at 1, 3, 7, 14, & 28 days after infusion.	Intention to treat.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score	Timepoints will be baseline, 1hr post-infusion and at 1, 3, 7, 14, & 28 days after infusion.	Intention to treat.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change in Beck Depression Inventory Score	Timepoints will be baseline, 1hr post-infusion and at 1, 3, 7, 14, & 28 days after infusion.	Intention to treat.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change in Beck Anxiety Inventory Score	Timepoints will be baseline, 1hr post-infusion and at 1, 3, 7, 14, & 28 days after infusion.	Intention to treat.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change in Zanarini Rating Scale for Borderline Personality Disorder	Timepoints will be baseline and at 1, 3, 7, 14, & 28 days after infusion.	Intention to treat.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change in Preferred Distance in Stop-distance Paradigm (SDP)	Timepoints will be at baseline and 3, 7, 14, 28 days after infusion	Intention to treat.	distance in inches	LEAST_SQUARES_MEAN
SECONDARY	Change in Behavior in the Economic Trust Game - Cooperation	Timepoints will be at baseline and 3, 7, 14, 28 days after infusion	Intention to treat.	proportion of amount returned	LEAST_SQUARES_MEAN

1 to 10 of 21Source ClinicalTrials.gov

See all 21 outcomes

Results by group210

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change in Suicidal Thoughts as Measured by Item 10 on the Montgomery-Asberg Depression Scale (MADRS)	Midazolam	baseline	2.66	Standard Error 0.37	units on a scale
Change in Suicidal Thoughts as Measured by Item 10 on the Montgomery-Asberg Depression Scale (MADRS)	Low Dose Ketamine	baseline	2.7	Standard Error 0.41	units on a scale
Change in Suicidal Thoughts as Measured by Item 10 on the Montgomery-Asberg Depression Scale (MADRS)	Midazolam	1hr post-infusion	0.0	Standard Error 0.37	units on a scale
Change in Suicidal Thoughts as Measured by Item 10 on the Montgomery-Asberg Depression Scale (MADRS)	Low Dose Ketamine	1hr post-infusion	0.1	Standard Error 0.41	units on a scale
Change in Suicidal Thoughts as Measured by Item 10 on the Montgomery-Asberg Depression Scale (MADRS)	Midazolam	Day 1 post-infusion	0.59	Standard Error 0.38	units on a scale
Change in Suicidal Thoughts as Measured by Item 10 on the Montgomery-Asberg Depression Scale (MADRS)	Low Dose Ketamine	Day 1 post-infusion	0.5	Standard Error 0.41	units on a scale
Change in Suicidal Thoughts as Measured by Item 10 on the Montgomery-Asberg Depression Scale (MADRS)	Midazolam	Day 3 post-infusion	0.89	Standard Error 0.38	units on a scale
Change in Suicidal Thoughts as Measured by Item 10 on the Montgomery-Asberg Depression Scale (MADRS)	Low Dose Ketamine	Day 3 post-infusion	0.7	Standard Error 0.41	units on a scale
Change in Suicidal Thoughts as Measured by Item 10 on the Montgomery-Asberg Depression Scale (MADRS)	Midazolam	Day 7 post-infusion	0.83	Standard Error 0.37	units on a scale
Change in Suicidal Thoughts as Measured by Item 10 on the Montgomery-Asberg Depression Scale (MADRS)	Low Dose Ketamine	Day 7 post-infusion	0.8	Standard Error 0.41	units on a scale

1 to 10 of 210Source ClinicalTrials.gov

See all 210 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Midazolam	12
Overall Study	STARTED	Low Dose Ketamine	10
Overall Study	COMPLETED	Midazolam	12
Overall Study	COMPLETED	Low Dose Ketamine	10
Overall Study	NOT COMPLETED	Midazolam	0
Overall Study	NOT COMPLETED	Low Dose Ketamine	0

Source ClinicalTrials.gov

Adverse events20

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Vivid dreams	Nervous system disorders	Midazolam	7	12	13
other	Vivid dreams	Nervous system disorders	Low Dose Ketamine	6	10	23
other	Blurry/double vision	Nervous system disorders	Midazolam	2	12	3
other	Blurry/double vision	Nervous system disorders	Low Dose Ketamine	3	10	9
other	Jerky muscle movements	Musculoskeletal and connective tissue disorders	Midazolam	1	12	2
other	Jerky muscle movements	Musculoskeletal and connective tissue disorders	Low Dose Ketamine	3	10	10
other	Nausea or vomiting	Gastrointestinal disorders	Midazolam	3	12	10
other	Nausea or vomiting	Gastrointestinal disorders	Low Dose Ketamine	4	10	12
other	Diarrhea	Gastrointestinal disorders	Midazolam	2	12	6
other	Diarrhea	Gastrointestinal disorders	Low Dose Ketamine	1	10	1

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Midazolam	0	12
Total, all-cause mortality	Low Dose Ketamine	0	10
Total, other adverse events	Midazolam	7	12
Total, other adverse events	Low Dose Ketamine	6	10
Total, serious adverse events	Midazolam	0	12
Total, serious adverse events	Low Dose Ketamine	0	10

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Midazolam vs Low Dose Ketamine: Change in Adverse Events	Trial comparisons
Midazolam vs Low Dose Ketamine: deaths from any cause	Trial comparisons
Midazolam vs Low Dose Ketamine: serious adverse events	Trial comparisons

Tests2

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source
Implicit Association Test (IAT)	Other outcome	ConductCognition
Trust Game	Secondary outcome	ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03395314

GET https://conductscience.org/api/trials/v1/NCT03395314/registered?page=2

API reference For AI assistants