Ketamine Infusion for Treatment-resistant Major Depressive Disorder

• ClinicalTrials.gov Identifier: NCT01582945
• Recruitment Status: Completed
• First Posted: April 23, 2012
• Results First Posted: April 20, 2017
• Last Update Posted: April 20, 2017
• Sponsor: Massachusetts General Hospital
• Information provided by (Responsible Party): Cristina Cusin, MD, Massachusetts General Hospital

Tracking Information

• First Submitted Date: April 17, 2012
• First Posted Date: April 23, 2012
• Results First Submitted Date: March 2, 2017
• Results First Posted Date: April 20, 2017
• Last Update Posted Date: April 20, 2017
• Study Start Date: April 2012
• Actual Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 18, 2017)

Response to Ketamine as Measured by Hamilton Depression Rating Scale -28 Items (HAMD28) [ Time Frame: 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.

Original Primary Outcome Measures (submitted: April 19, 2012)

Hamilton Depression Rating Scale -28 items [ Time Frame: 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

• Current Secondary Outcome Measures: Not Provided

Original Secondary Outcome Measures (submitted: April 19, 2012)

Systematic Assessment for Treatment Emergent Events (SAFTEE) [ Time Frame: Weekly for total duration of 4 months ]

Patients will be monitored for emergence of side effects weekly for the first 8 weeks, then every two weeks for 8 weeks

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Ketamine Infusion for Treatment-resistant Major Depressive Disorder
• Official Title: N-methyl-D-aspartate Antagonist (Ketamine) Infusion for Treatment-resistant Major Depressive Disorder With Suicidal Ideation

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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Major Depressive Disorder

Intervention

Drug: Ketamine

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

Study Arms

Experimental: Ketamine IV

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

Intervention: Drug: Ketamine

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 18, 2017): 14
• Original Estimated Enrollment (submitted: April 19, 2012): 20
• Actual Study Completion Date: December 2014
• Actual Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01582945
• Other Study ID Numbers: 2010-P-002800
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Cristina Cusin, MD, Massachusetts General Hospital
• Study Sponsor: Massachusetts General Hospital
• Collaborators: Not Provided

Investigators

• Principal Investigator: Cristina Cusin, MD; MGH Department of Psychiatry

• PRS Account: Massachusetts General Hospital
• Verification Date: April 2017