Ketamine Versus Placebo for Treatment Resistant Major Depressive Disorder
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|