Double-Blind, Placebo-Controlled Trial of Ketamine Therapy in Treatment-Resistant Depression (TRD)

Summary

This study is looking at the efficacy, durability, safety, and tolerability of multiple single doses of Ketamine vs. active placebo for treating patients with treatment resistant depression who are taking an antidepressant that is not working for them.

Conditions

• Treatment Resistant Depression

Interventions

DRUG

Ketamine

Dose of Ketamine will be 0.1 mg/kg - one single infusion

DRUG

Ketamine

Dose of Ketamine will be 0.2 mg/kg - one single infusion

DRUG

Ketamine

Dose of Ketamine will be 0.5 mg/kg - one single infusion

DRUG

Ketamine

Dose of Ketamine will be 1.0 mg/kg - one single infusion

DRUG

Placebo Midazolam

Dose of Midazolam (active placebo) will be 0.045 mg/kg - one single infusion

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Baylor College of Medicine

  collaborator OTHER

• Icahn School of Medicine at Mount Sinai

  collaborator OTHER

• Stanford University

  collaborator OTHER

• University of Texas

  collaborator OTHER

• Yale University

  collaborator OTHER

• 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

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-12-31

Primary Completion

2017-01-31

Completion

2017-02-28

Countries

• United States

Study Locations