NCT01920555

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objective is to investigate whether all doses (0.1 mg/kg, 0.2 mg/kg, 0.5 mg/kg, and 1.0 mg/kg) of ketamine are superior to active placebo (midazolam 0.045 mg/kg) therapy in the acute treatment of patients with treatment resistant depression within 72 hours (Day 3), when added to ongoing and stable antidepressant therapy.

Conditions

• Treatment Resistant Depression

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-12-01
• Primary completion: 2017-01-01
• Completion: 2017-02-01
• First posted: 2013-08-12
• Last updated: 2018-06-19
• Results posted: 2018-04-17

Locations

6 sites across 1 country: United States