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Ketamine in Borderline Personality Disorder

NCT03395314 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2023-06-26

Study results available
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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.

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.

Conditions

  • Borderline Personality Disorder

Interventions

DRUG

Ketamine

1 single dose of IV ketamine

DRUG

Midazolam

1 single dose of IV midazolam

Sponsors & Collaborators

  • Nathan Kline Institute for Psychiatric Research

    collaborator OTHER

  • American Foundation for Suicide Prevention

    collaborator OTHER

  • Yale University

    lead OTHER

Principal Investigators

  • Sarah Fineberg, MD/PhD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-15
Primary Completion
2022-05-06
Completion
2022-05-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03395314 on ClinicalTrials.gov