Ketamine Infusion for Treatment-resistant Major Depressive Disorder

Not Applicable

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: Ketamine

• Registration Number: NCT01582945
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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).

Detailed 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.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-17
• Study First Submitted QC: 2012-04-19
• Study First Posted: 2012-04-23
• Primary Completion: 2014-09
• Study Completion: 2014-12
• Results First Submitted: 2017-03-02
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-18
• Last Update Submitted: 2017-04-18
• Results First Posted: 2017-04-20
• Last Update Posted: 2017-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Response to Ketamine as Measured by Hamilton Depression Rating Scale -28 Items (HAMD28)	Weekly for total duration of 4 months	Patients will be assessed with HAMD-28 weekly for the first 8 weeks, then every two weeks for another 8 weeks. Participants were considered as responders if there was a ⩾50% improvement on the HAM-D28.

Trial Locations

Locations (1)

Depression Clinical and Research Program - MGH; 🇺🇸 Boston, Massachusetts, United States