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Ketamine for Suicidality in Bipolar Depression

NCT01944293 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2020-03-11

Study results available
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Summary

This study is designed to compare the effectiveness of two medications, Ketamine and Midazolam, for rapidly relieving suicidal thoughts in people suffering from bipolar depression.

The first drug, ketamine, is an experimental antidepressant that early studies have shown may quickly reduce suicidal thoughts, but we are not sure how well it may work. Midazolam, the comparison drug, is not thought to reduce depression or suicidal thoughts.

Conditions

Interventions

DRUG

Ketamine

Single dose of 0.5 mg/kg of Ketamine given intravenously (in the vein) over 40 minutes

DRUG

Midazolam

Single dose of 0.02 mg/kg of Midazolam given intravenously (in the vein) over 40 minutes

Sponsors & Collaborators

  • Brain & Behavior Research Foundation

    collaborator OTHER

  • New York State Psychiatric Institute

    lead OTHER

Principal Investigators

  • Michael F Grunebaum, M.D. · Columbia Unviversity/New York State Psychiatric Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2017-09-30
Completion
2018-10-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT01944293 on ClinicalTrials.gov