Ketamine Versus Placebo for Treatment Resistant Major Depressive Disorder

NCT ID: NCT01667926

Last Updated: 2017-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2015-11-30

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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Ketamine

Subject will receive 6 infusions of ketamine over three weeks.

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Ketamine

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

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Cristina Cusin, MD

Instructor HSM

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cristina Cusin, M.D.

Role: PRINCIPAL_INVESTIGATOR

MGH Department of Psychiatry

Locations

Depression Clinical and Reseach Program - MGH

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2012-P-001042

Identifier Type: -

Identifier Source: org_study_id