Novel Medication Strategies Targeting Brain Mechanisms in Pediatric OCD
This study will examine the feasibility and potential efficacy of augmenting SRIs with minocycline. The study will assess whether the addition of minocycline leads to measurable changes in striatal glutamate (Glu) levels. This study will recruit 45 youth ages 8-20 diagnosed with clinically significant OCD who have demonstrated no more than minimal response to SRI treatment and are currently on a stable dose of SRI medication for at least 12 weeks. Participants will be randomized to receive either 12 weeks of minocycline treatment or pill placebo. Randomization will be 2:1 so that 2 of 3 participants receive minocycline. Screening for eligibility will take place for 1-4 weeks. Participants will undergo MRS scans to measure striatal Glu levels prior to randomization, and again immediately following the treatment period. During the treatment period, participants will meet initially weekly and then every other week with the study psychiatrist. All participants will be offered three months of open medication treatment following participation. The clinical trial will only be conducted at NYSPI and the MRS scans may be conducted at Weill Cornell Medical Center or NYSPI.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|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|
- Yale-Brown Obsessive Compulsive Scale, Child version (CYBOCS) [ Time Frame: Change from Baseline at 4, 8, and 12 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]The change in striatal glutamate level will be assessed.
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||May 2015|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
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
Please see the brief summary for study description.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01695291
|Contact: Moira Rynn, M.D.||(646) 774-5805||RynnM@nyspi.columbia.edu|
|Contact: Prerna Martin, MPH||(646) firstname.lastname@example.org|
|United States, New York|
|New York State Psychiatric Institute||Recruiting|
|New York, New York, United States, 10032|
|Contact: Moira Rynn, M.D. 646-774-5805 RynnM@nyspi.columbia.edu|
|Contact: Prerna Martin, MPH (646) 774-5793 email@example.com|
|Principal Investigator: Moira Rynn, M.D.|
|Sub-Investigator: Helen Blair Simpson, M.D.|
|Sub-Investigator: Lawrence Kegeles, M.D.|
|Weill Cornell Medical Center||Recruiting|
|New York, New York, United States, 10021|
|Contact: Dikoma Shungu, Ph.D. 212-746-2481 firstname.lastname@example.org|
|Sub-Investigator: Dikoma Shungu, Ph.D.|
|Principal Investigator:||Moira A Rynn, MD||Columbia University/NYSPI|