Novel Medication Strategies Targeting Brain Mechanisms in Pediatric OCD
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|ClinicalTrials.gov Identifier: NCT01695291|
Recruitment Status : Active, not recruiting
First Posted : September 27, 2012
Last Update Posted : March 30, 2017
|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|
|Estimated Study Completion Date :||March 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.
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): 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|