Ketamine Treatment for Pediatric-Refractory Obsessive-Compulsive Disorder (OCD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02422290|
Recruitment Status : Completed
First Posted : April 21, 2015
Last Update Posted : August 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Obsessive-Compulsive Disorder||Drug: Ketamine||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ketamine Treatment for Pediatric-Refractory Obsessive-Compulsive Disorder (OCD)|
|Study Start Date :||March 2015|
|Actual Primary Completion Date :||January 1, 2018|
|Actual Study Completion Date :||January 1, 2018|
Experimental: Adolescents and young adults with OCD
All participants will be receive the intravenous ketamine infusion.
Single infusion of IV Ketamine, 0.5mg/kg
Other Name: Ketalar
- Yale-Brown Obsessive Compulsive Scale, Child version (CYBOCS) [ Time Frame: Change from Baseline at Day 7 and Day 14 ]The CYBOCS is a semi-structured measure of OCD severity with excellent inter-rater reliability, internal consistency, and test-retest reliability. It is validated in those starting at age 7 and used in studies up to age 20. The CYBOCS differs from the adult YBOCS only in its use of simpler language.
- Clinical Global Impressions Scale (CGI-S) [ Time Frame: Change from Baseline at Day 3, Day 7, and Day 14 ]The Clinical Global Impressions scale is a clinician rated instrument providing a single score for severity and improvement (from a 7-point scale) comparing the patient's condition throughout the study to the condition at baseline (before the ketamine infusion).
- OCD Visual Analogue Scale (OCD-VAS) [ Time Frame: Change from Baseline at 20 minutes into the infusion, immediately after the infusion is completed, and each day after the infusion for 14 days. ]A one-item scale to assess OCD symptoms over a rapid time frame. Patients will be asked to report their rating on this scale prior to, during and after the infusion and daily during the 14 period following the infusion.
- Yale-Brown Obsessive Compulsive Challenge Scale (YBOCCS) [ Time Frame: Change from Baseline at each day after the infusion for 14 days. ]A brief self-report scale to assess rapid changes in OCD symptoms. Patients will be asked to report their rating on this scale prior to, during and after the infusion.
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): NCT02422290
|United States, New York|
|New York State Psychiatric Institute/Columbia University|
|New York, New York, United States, 10032|
|Principal Investigator:||Pablo Goldberg, M.D.||Columbia University/NYSPI|