CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 51 enrolled
Drug / intervention
Brexpiprazole +2 moredrug
Likely dose
Brexpiprazole 3mgfrom 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/NCT03149991
NCT03149991Phase 4Completed
CompareCT.gov

A Double-Blind, Placebo-Controlled Study of Brexpiprazole Plus Ketamine in Treatment-Resistant Depression (TRD)

Massachusetts General Hospital·interventional·Posted May 11, 2017·Updated Jul 24, 2020

In Brief

A Phase 4 clinical trial evaluating Brexpiprazole, Ketamine, and 1 other intervention for Depression. Completed, enrolled 51 participants across 6 sites.

Detailed Summary

This is a multi-site, double-blind, placebo-controlled study of the acute efficacy of brexpiprazole or placebo in combination with intranasal ketamine added to ongoing, stable, and adequate antidepressant therapy (ADT) in the treatment of adults with Major Depressive Disorder with Treatment Resistant Depression.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedMay 11, 2017
Enrollment StartSep 14, 2017
Primary CompletionMar 31, 2019
Study CompletionJun 15, 2019
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 9.1 years ago

Interventions

Brexpiprazoledrug

Administration of up to 3mg brexpiprazole

Ketaminedrug

administration 6 times over two weeks of inhaled ketamine

Placebodrug

Administration of placebo which matches brexpiprazole in size and number of tablets per dose