2/2 D-Cycloserine Augmentation of CBT for Pediatric OCD
The purpose of this study is to find out if D-Cycloserine (DCS), taken at the same time as a child gets cognitive behavioral therapy (CBT) can help children with pediatric obsessive-compulsive disorder.
Cognitive Behavior Therapy is a talking therapy that will teach children new skills to better cope with his/her OCD. CBT usually uses "exposure-based therapy". This means that the person with OCD slowly learns to deal with things they usually avoid. This is done by moving from less stressful situations to more challenging ones.
The investigators hope to enroll about 75 children ages 7-17 years old with OCD in this study at Massachusetts General Hospital (MGH). The National Institute of Mental Health (NIMH) is paying for this study to be done.
If your child qualifies for the study, the investigators will assign him or her by chance (like a coin toss) to either the DCS group or the placebo group. You and the study doctor cannot choose your child's study group. Your child will have an equal chance (1 in 2) of being assigned to the DCS group.
Your child will be asked to take one or two capsules of the study drug (either DCS or placebo, depending which study group they were assigned to) one hour before CBT visits 4-10. The study coordinator will give your child the study drug at the location of the CBT sessions. This is to make sure that your child takes the study drug one hour before his/her scheduled therapy session. We will ask you to record any bad side effect from the study drug that your child may have before each CBT session.
It will take your child about 34 weeks to complete the study. During this time, the investigators will ask you and your child to make a minimum of 17 trips to the study center. There may be up to 23 trips when including CBT Booster sessions.
This study uses a placebo. The placebo looks exactly like the DCS, but it contains no DCS. The investigators use placebos in research studies to learn if the the results are caused by the study drug or are due to other reasons. This is a double-blind study. A double-blind study is a study where both the doctor and the study participant do not know whether the study participant is being given DCS or placebo.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||2/2 D-Cycloserine Augmentation of CBT for Pediatric OCD|
- Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) [ Time Frame: Change from Score at Baseline to Follow Up (34 weeks) ] [ Designated as safety issue: No ]Measure of severity of OCD symptoms, including interference, time spent on thoughts or behaviors, distress, resistance, etc.
- Clinical Global Impression-Improvement [ Time Frame: Change from Drug Randomization Point to Follow Up (34 weeks) ] [ Designated as safety issue: No ]
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||September 2015|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
|Active Comparator: D-Cycloserine||
25mg dose for children weighing between 22.5kg and 45kg (dose = approx. .7mg/kg) 50mg dose for children weighing greater than 46kg (dose = approx. .7mg/kg) Dose given 7 times, every seven days, except for the third dose, which will be given three days after the second dose. All doses given 1 hour prior to therapy session.
|Placebo Comparator: Sugar Pill||
Please refer to this study by its ClinicalTrials.gov identifier: NCT01404208
|Contact: Daniel A Geller, M.D.||firstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Daniel A Geller, M.D. 617-724-5141 email@example.com|
|Principal Investigator: Daniel A Geller, M.D.|
|Sub-Investigator: Sabine Wilhelm, Ph.D.|
|Principal Investigator:||Daniel A Geller, M.D.||Massachusetts General Hospital|