Ketamine Versus Placebo for Treatment Resistant Major Depressive Disorder
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Randomized, Double-blind Ketamine Augmentation in Chronically Suicidal, Treatment-resistant Major Depression|
- Hamilton Depression Rating Scale - 28 Items [ Time Frame: up to 4 months ] [ Designated as safety issue: No ]Subjects will be assessed with HAM-D
- Systematic Assessment for Treatment Emergent Events (SAFTEE) [ Time Frame: up to 5 months ] [ Designated as safety issue: Yes ]Subjects will be monitored for emergence of side effects weekly for the first 8 weeks and then every two weeks for 8 weeks.
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||October 2016|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
Subject will receive 6 infusions of ketamine over three weeks.
ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen.
Placebo Comparator: Placebo
Subjects will receive 6 infusions of normal saline over 3 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01667926
|Contact: Cristina Cusin, M.D.||firstname.lastname@example.org|
|United States, Massachusetts|
|Depression Clinical and Reseach Program - MGH||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Cristina Cusin, M.D. 617-726-6421 email@example.com|
|Principal Investigator: Cristina Cusin, M.D.|
|Principal Investigator:||Cristina Cusin, M.D.||MGH Department of Psychiatry|