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

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.

Status Completed
Results Published
Start date 01 December 2014
End date 01 February 2017
Chance of happening 100%
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 99
Sex All
Age 18- 69
Therapy No

Trial Details

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.

NCT Number NCT01920555

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.

National Institute of Mental Health
This company doesn't have a full profile yet, it is linked to a clinical trial.

Baylor College of Medicine
This company doesn't have a full profile yet, it is linked to a clinical trial.

Icahn School of Medicine at Mount Sinai
This company doesn't have a full profile yet, it is linked to a clinical trial.

Stanford University
Researchers at Stanford are exploring the potential of ketamine, MDMA and psilocybin by connecting neuroscience, psychiatry and anesthesiology.

University of Texas
The University of Texas is conducting research with psychedelics across locations in Houston, Austin, Dallas and San Antonio.

Yale University
The Yale Psychedelic Science Group was established in 2016.


Factors Associated with Antidepressant Effects of Ketamine: A Reanalysis of Double-Blind Randomized Placebo-Controlled Trial of Intravenous Ketamine for Treatment-Resistant Depression
This study analyzed data from an RCT (n=31) with treatment-resistant depression (TRD) who received therapeutic doses of intravenous ketamine (35 to 70mg/70kg). The research found that a later onset of depression was positively correlated with a better treatment response to ketamine after three days of administration, suggesting that earlier disease onset may be associated with impaired glutamatergic signal transmission and reduced neuroplasticity, which diminishes the response to ketamine. Other demographic and clinical factors, including age, sex, baseline depression score, and dissociative score, didn't significantly correlate with treatment response.

Measures Used

Hamilton Depression Rating Scale
The Hamilton Depression Rating Scale (HDRS) is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluating recovery. The scale consists of 17 items which each item being scoring on a 3 or 5 point scale. The higher the score, the more likely a person is depressed.

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.

Clinical-Administered Dissociative Symptoms Scale
The Clinical-Administered Dissociative Symptoms Scale (CADSS) is a scale used to measure dissociative states such as those induced by ketamine.

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

Data attribution

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