Intranasal Ketamine in Treatment-Resistant Depression
This study is currently recruiting participants.
Verified December 2013 by Mount Sinai School of Medicine
Information provided by (Responsible Party):
James Murrough, Mount Sinai School of Medicine
First received: February 23, 2011
Last updated: December 19, 2013
Last verified: December 2013
The objective of the current study is to investigate the safety and efficacy of a single dose of intranasal (IN) ketamine in treatment-resistant depression (TRD).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Intranasal (IN) Ketamine in Treatment-Resistant Depression (TRD)|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Mount Sinai School of Medicine:
Primary Outcome Measures:
- Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Systematic Assessment for Treatment Emergent Effects (SAFTEE) [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||July 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01304147
|Contact: Cara Levitchfirstname.lastname@example.org|
|United States, New York|
|Icahn School of Medicine at Mount Sinai||Recruiting|
|New York City, New York, United States, 10029|
|Contact: Cara Levitch 212-241-3116 email@example.com|
|Principal Investigator: James W Murrough, MD|
|Sub-Investigator: Kyle Lapidus, MD, PhD|
|Sub-Investigator: Dan Iosifescu, MD|
|Sub-Investigator: Laili Someilani, MD|
|Sub-Investigator: Andrew Perez, MD|
|Sub-Investigator: LeBen Wan, MD|
Sponsors and Collaborators
|Principal Investigator:||James W Murrough, MD||Mount Sinai School of Medicine|