Ketamine Versus Placebo for Treatment Resistant Major Depressive Disorder

Not Applicable

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: Placebo; Drug: Ketamine

• Registration Number: NCT01667926
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

Ketamine infusions resulted in an acute reduction in global depression scores and in severity of suicidal ideation. The investigators therefore plan to investigate the feasibility and efficacy of repeated intravenous administration of ketamine in severely depressed, treatment resistant patients. The results of the study could lead to development of new strategies for treating depression.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-15
• Study First Submitted QC: 2012-08-16
• Study First Posted: 2012-08-17
• Study Start: 2013-01
• Primary Completion: 2015-10
• Study Completion: 2015-11
• Results First Submitted: 2017-03-02
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-18
• Last Update Submitted: 2017-04-18
• Results First Posted: 2017-04-20
• Last Update Posted: 2017-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

• Outpatient with sever treatment resistant depression
• Currently depressed
• Currently under regular psychiatric care
• On an aggressive antidepressant regimen, stable for 4 weeks.

Exclusion Criteria

• No history of other major psychiatric illness, including bipolar
• No history of psychosis
• No history of drug abuse
• No major medical illness or unstable medical problem

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subjects will receive 6 infusions of normal saline over 3 weeks.
Ketamine	Ketamine	Subject will receive 6 infusions of ketamine over three weeks.

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale - Suicidal Ideation (HDRS-SI)	up to 4 months	The HDRS-SI score consists of a single item on the Hamilton Depression Rating Scale (HDRS). Scores range from 0 to 4, with 0 representing no suicidal ideation, and 4 representing a suicide attempt.

Secondary Outcome Measures

Name	Time	Method
HDRS-28 Total	up to 5 months	Hamilton Depression Rating Scale Total scores after completing 6 infusions. Scores may range from 0-81 with higher scores indicating greater depression severity. HDRS-28 score ≤ 7 was considered remission.

Trial Locations

Locations (1)

Depression Clinical and Reseach Program - MGH; 🇺🇸 Boston, Massachusetts, United States