2/2 D-Cycloserine Augmentation of CBT for Pediatric OCD

Mass General Brigham

Status

Completed

Conditions

Obsessive-Compulsive Disorder

Treatments

Drug: Placebo

Drug: D-Cycloserine

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01404208

2011P000875

1R01MH093402-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

206 patients

Sex

All

Ages

7 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Clinical diagnosis of Obsessive-Compulsive Disorder as primary or co-primary diagnosis
Score on CY-BOCS of 16 or greater
Full Scale IQ greater than or equal to 85
English speaking

Exclusion criteria

Receiving concurrent psychotherapy or a past adequate trial of CBT for OCD
Initiation of an antidepressant within 12 weeks before study enrollment
Initiation of an antipsychotic within 6 weeks before study enrollment
No new alternative medications, nutritionals, or therapeutic diets within 6 weeks of study enrollment
Any change in established psychotropic medication within 8 weeks before study enrollment (6 weeks for antipsychotic). Alternative medications must be stable for 6 weeks prior to baseline. Any medications must remain stable during treatment.
Current clinically significant suicidality
Suicidal behaviors within six months
DSM-IV conduct disorder
DSM-IV autism
DSM-IV bipolar
DSM-IV schizophrenia or schizo-affective disorders
Substance abuse within the past six months
Hoarding symptoms (due to difficulty implementing E/RP tasks)
Weight less than 22.5k
Epilepsy or renal insufficiency
Current and/or past history of alcohol abuse (DCS is contraindicated)
Pregnant or having unprotected sex (in females)
Presence of a significant and/or unstable medical illness that might lead to hospitalization during the study
Known DCS allergy