Ketamine Versus Placebo for Treatment Resistant Major Depressive Disorder

Major Depressive Disorder Clinical Trial

Official title:

Randomized, Double-blind Ketamine Augmentation in Chronically Suicidal, Treatment-resistant Major Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01667926
• Other study ID #: 2012-P-001042
• Status: Completed
• Phase: N/A
• First received: August 15, 2012
• Last updated: April 18, 2017
• Start date: January 2013
• Est. completion date: November 2015

Study information

• Verified date: April 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Ketamine
ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen.
• Placebo

Locations

Country	Name	City	State
United States	Depression Clinical and Reseach Program - MGH	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Rating Scale - Suicidal Ideation (HDRS-SI)	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.	up to 4 months
Secondary	HDRS-28 Total	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.	up to 5 months