CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 16 enrolled
Drug / intervention
Ketamine +1 moredrug
Likely dose
Ketamine 0.5 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01944293
NCT01944293Phase 2Completed
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Ketamine vs. Midazolam in Bipolar Depression

New York State Psychiatric Institute·interventional·Posted Sep 17, 2013·Updated Mar 11, 2020

In Brief

A Phase 2 clinical trial evaluating Ketamine and Midazolam for Bipolar Disorder and 2 related conditions. Completed, enrolled 16 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder, Major Depressive Episode, Suicidal Ideation
CountriesUnited States
CollaboratorsBrain & Behavior Research Foundation

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 17, 2013
Enrollment StartSep 1, 2013
Primary CompletionSep 1, 2017
Study CompletionOct 1, 2018
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 12.8 years ago

Interventions

Ketaminedrug

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

Midazolamdrug

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