Ketamine Versus Placebo for Treatment Resistant Major Depressive Disorder

Massachusetts General Hospital37 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Major Depressive Disorder

Interventions

KetamineDRUG

ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen.

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Depression Clinical and Reseach Program - MGH

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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.

Time frame: up to 4 months

Secondary Outcomes

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.

Time frame: up to 5 months

Data from ClinicalTrials.gov

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