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

NCT03149991 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2020-07-24

Study results available
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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.

Conditions

Interventions

DRUG

Brexpiprazole

Administration of up to 3mg brexpiprazole

DRUG

Ketamine

administration 6 times over two weeks of inhaled ketamine

DRUG

Placebo

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

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Maurizio Fava, MD · Massachusetts General Hospital

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
2017-09-14
Primary Completion
2019-03-31
Completion
2019-06-15
FDA Drug
Yes

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 NCT03149991 on ClinicalTrials.gov