Intranasal Ketamine in Treatment-Resistant Depression
|ClinicalTrials.gov Identifier: NCT01304147|
Recruitment Status : Completed
First Posted : February 25, 2011
Results First Posted : February 8, 2017
Last Update Posted : February 8, 2017
|Condition or disease||Intervention/treatment|
|Major Depressive Disorder||Drug: Ketamine Drug: placebo|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Intranasal (IN) Ketamine in Treatment-Resistant Depression (TRD)|
|Study Start Date :||October 2011|
|Primary Completion Date :||October 2014|
|Study Completion Date :||October 2014|
Subjects randomized to this arm will receive the active study medication, intranasal ketamine.
A single dose of intranasal ketamine up to 50 mg
Placebo Comparator: Placebo
Subjects randomized to this arm will receive intranasal saline.
Single dose of saline intranasal
- Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 24 hours ]
Number of patients meeting response criteria of >=50% decrease in MADRS score from baseline , ie, difference in depressive symptoms using MADRS instrument, 24 hours following drug administration
10-item instrument used for the evaluation of depressive symptoms in adults and for the assessment of any changes to those symptoms. Each of the 10 items is rated on a scale of 0 to 6, with differing descriptors for each item. These individual item scores are added together to form a total score, which can range between 0 and 60 points.
- Systematic Assessment for Treatment Emergent Effects (SAFTEE) [ Time Frame: 2 weeks ]This is a self-report measure for systematically assessing 48 possible adverse events. It documents their severity, relationship to study drug, and the action taken.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01304147
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York City, New York, United States, 10029|
|Principal Investigator:||James W Murrough, MD||Icahn School of Medicine at Mount Sinai|