2/2 D-Cycloserine Augmentation of CBT for Pediatric OCD
Condition: Obsessive-Compulsive Disorder
MeSH terms: Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      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.
    


Intervention name(s): D-Cycloserine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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.; Sugar pill
Intervention MeSH terms: Cycloserine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment