Novel Medication Strategies Targeting Brain Mechanisms in Pediatric OCD
|ClinicalTrials.gov Identifier: NCT01695291|
Recruitment Status : Completed
First Posted : September 27, 2012
Last Update Posted : July 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Obsessive Compulsive Disorder||Drug: Minocycline Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomized, Placebo-controlled Trial of Minocycline Added to Serotonin Reuptake Inhibitors in Pediatric OCD: Examining the Effects on Clinical Symptoms and on Brain Glutamate Levels Using MRS Imaging|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||February 2017|
|Actual Study Completion Date :||January 2018|
Placebo Comparator: Placebo
Participants randomized to placebo will receive pills that are identical in appearance to the study drug but contain no active medication.
A placebo pill will be administered BID for 12 weeks.
Experimental: Minocycline Augmentation
Those randomized to minocycline will receive approximately 2 mg/kg/day, the FDA-approved dose for minocycline (minimum 50 mg/day and maximum 200 mg/day). After randomization, participants will receive child proofed bottles that contain enough study medication until the next visit with an additional 3 days coverage in case of scheduling issues. All participants will have a minocycline level drawn at week 12 to confirm treatment adherence. Minocycline is FDA-approved in those ages 8 and above for treatment of infections and acne and has a favorable risk-benefit profile.
Participants randomized to minocycline will receive approximately 2 mg/kg/day, the FDA-approved dose for minocycline. Participants will take either minocycline or pill placebo for 12 weeks.
Other Name: Minomycin, Minocin, Arestin, Aknemin, Solodyn and Dynacin
- Yale-Brown Obsessive Compulsive Scale, Child version (CYBOCS) [ Time Frame: Change from Baseline at 4, 8, and 12 weeks ]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.
- Striatal glutamate level measured by MRS. [ Time Frame: Change from Baseline at 12 weeks ]The change in striatal glutamate level will be assessed.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01695291
|United States, New York|
|Weill Cornell Medical Center|
|New York, New York, United States, 10021|
|New York State Psychiatric Institute|
|New York, New York, United States, 10032|
|Principal Investigator:||Moira A Rynn, M.D.||Columbia University/NYSPI|