Ketamine Infusion for Treatment-resistant Major Depressive Disorder

NCT ID: NCT01582945

Last Updated: 2017-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2014-12-31

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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ketamine IV

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

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: DRUG

Ketamine IV 0.5mg/kg infusion twice a week for 3 weeks as augmentation of ongoing antidepressant regimen

Interventions

Ketamine

Ketamine IV 0.5mg/kg infusion twice a week for 3 weeks as augmentation of ongoing antidepressant regimen

Intervention Type: DRUG

Eligibility Criteria

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

• 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 HMS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cristina Cusin, MD

Role: PRINCIPAL_INVESTIGATOR

MGH Department of Psychiatry

Locations

Depression Clinical and Research Program - MGH

Boston, Massachusetts, United States

Countries

United States

References

Ionescu DF, Swee MB, Pavone KJ, Taylor N, Akeju O, Baer L, Nyer M, Cassano P, Mischoulon D, Alpert JE, Brown EN, Nock MK, Fava M, Cusin C. Rapid and Sustained Reductions in Current Suicidal Ideation Following Repeated Doses of Intravenous Ketamine: Secondary Analysis of an Open-Label Study. J Clin Psychiatry. 2016 Jun;77(6):e719-25. doi: 10.4088/JCP.15m10056.

Reference Type: RESULT

PMID: 27232360 (View on PubMed)

Cusin C, Ionescu DF, Pavone KJ, Akeju O, Cassano P, Taylor N, Eikermann M, Durham K, Swee MB, Chang T, Dording C, Soskin D, Kelley J, Mischoulon D, Brown EN, Fava M. Ketamine augmentation for outpatients with treatment-resistant depression: Preliminary evidence for two-step intravenous dose escalation. Aust N Z J Psychiatry. 2017 Jan;51(1):55-64. doi: 10.1177/0004867416631828.

Reference Type: RESULT

PMID: 26893373 (View on PubMed)

Other Identifiers

2010-P-002800

Identifier Type: -

Identifier Source: org_study_id