Ketamine Versus Placebo for Treatment Resistant Major Depressive Disorder
|ClinicalTrials.gov Identifier: NCT01667926|
Recruitment Status : Completed
First Posted : August 17, 2012
Results First Posted : April 20, 2017
Last Update Posted : April 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: Ketamine Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Randomized, Double-blind Ketamine Augmentation in Chronically Suicidal, Treatment-resistant Major Depression|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||November 2015|
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.
- Hamilton Depression Rating Scale - Suicidal Ideation (HDRS-SI) [ Time Frame: up to 4 months ]The HDRS-SI score consists of a single item on the Hamilton Depression Rating Scale (HDRS). Scores range from 0 to 4, with 0 representing no suicidal ideation, and 4 representing a suicide attempt.
- HDRS-28 Total [ Time Frame: up to 5 months ]Hamilton Depression Rating Scale Total scores after completing 6 infusions. Scores may range from 0-81 with higher scores indicating greater depression severity. HDRS-28 score ≤ 7 was considered remission.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01667926
|United States, Massachusetts|
|Depression Clinical and Reseach Program - MGH|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Cristina Cusin, M.D.||MGH Department of Psychiatry|