Ketamine Versus Placebo for Treatment Resistant Major Depressive Disorder

Mass General Brigham

Status: Completed

Conditions: Major Depressive Disorder

Treatments: Drug: Placebo; Drug: Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT01667926

2012-P-001042

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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37 participants in 2 patient groups, including a placebo group

Ketamine

Experimental group

Description:

Subject will receive 6 infusions of ketamine over three weeks.

Treatment:

Drug: Ketamine

Placebo

Placebo Comparator group

Description:

Subjects will receive 6 infusions of normal saline over 3 weeks.

Treatment:

Drug: Placebo