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NCT01404208 · ClinicalTrials.gov registry record · NA
2/2 D-Cycloserine Augmentation of CBT for Pediatric OCD
A NA study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- NA
- Development phase
- 206
- Enrollment target
NCT01404208: Completed NA study, sponsored by Massachusetts General Hospital.
NCT01404208 is a NA study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 206 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01404208, a NA study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 206 participants
- Enrollment target
Study 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
Interventions
- DRUG Placebo
- DRUG D-Cycloserine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 206 participants |
| Start Date | 2011-07 |
| Est. Completion | 2016-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01404208
The ClinicalTrials.gov registry entry for NCT01404208 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 206 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01404208 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01404208 about?
NCT01404208 is a clinical study titled "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 co...
What is the current status of trial NCT01404208?
This trial is currently completed. It is a NA study. The enrollment target is 206 participants. The study started on 2011-07. Estimated completion is 2016-12.
What interventions are being tested in trial NCT01404208?
The interventions under investigation include: Placebo (DRUG), D-Cycloserine (DRUG).
Who is sponsoring clinical trial NCT01404208?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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