Ketamine Infusion for Treatment-resistant Major Depressive Disorder

Mass General Brigham

Status: Completed

Conditions: Major Depressive Disorder

Treatments: Drug: Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT01582945

2010-P-002800

Details and patient eligibility

About

Ketamine infusion has been shown to have rapid antidepressant properties, however the possible use of ketamine in treatment-resistant depression as augmentation has not been investigated. The overall aim of this study is to assess the feasibility, safety and tolerability, efficacy and duration of the effect of intravenous N-methyl-D-aspartate antagonist ketamine as augmentation of antidepressants for chronic suicidal ideation in subjects with severe treatment-resistant depression (TRD).

This is an open-label study (pilot).

Full description

Patients will undergo two weeks of prospective observation, they will then receive ketamine IV 0.5mg/kg over 45 minutes as augmentation of their ongoing antidepressant regimen; after three infusions this dose will be increased increase to 0.75 mg/kg in non-responders. The schedule of administration will be twice a week for 3 weeks. After this phase, the patient will be followed with assessments every two weeks for three months.

Total duration of the study is 5 months.

Enrollment: 14 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Outpatients with severe treatment-resistant MDD
• Currently depressed
• Currently under regular psychiatric care
• On an aggressive antidepressant regimen, stable for 4 weeks

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Ketamine IV

Experimental group

Description:

Patients will receive open label augmentation with IV Ketamine at 0.5mg/kg, twice a week for 3 weeks

Treatment:

Drug: Ketamine