A Study of Brexpiprazole Plus Ketamine in Treatment-Resistant Depression (TRD)

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.

Topic Depression
Compound Ketamine Placebo
Country United States of America
Visit trial
Status Completed
Results Published
Start date 14 September 2017
End date 15 June 2019
Chance of happening 100%
Phase Phase IV
Design Blinded
Type Interventional
Generation First
Participants 51
Sex All
Age 18- 65
Therapy No

Trial Details

This is a five-site, double-blind, placebo-controlled study of the acute efficacy of oral brexpiprazole or placebo combined with intranasal ketamine added to ongoing, stable, and adequate antidepressant therapy (ADT) in the treatment of adults with MDD with TRD. Adequate ADT is defined as a therapeutically sufficient dose for a sufficient treatment period, which would be expected to be effective as listed in the MGH ATRQ.

NCT Number NCT03149991

Sponsors & Collaborators

Massachusetts General Hospital
Massachusettes General Hospital has launched the MGH Center for the Neuroscience of Psychedelics. The announcement has now been done via YouTube, and the formal launch will be in fall 2020.

Measures Used

Montgomery-Asberg Depression Rating Scale
A ten-item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders.

Symptoms of Depression Questionnaire
The Symptoms of Depression Questionnaire (SDQ) is a 44-item, self-report scale designed to measure the severity of symptoms across several subtypes of depression.

Data attribution

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