Ignite Creation Date:
2024-05-05 @ 11:44 PM
Last Modification Date:
2024-10-26 @ 10:38 AM
Study NCT ID:
NCT01404208
Status:
COMPLETED
Last Update Posted:
2017-03-28
First Post:
2011-07-25
Brief Title:
22 D-Cycloserine Augmentation of CBT for Pediatric OCD
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
22 D-Cycloserine Augmentation of CBT for Pediatric OCD
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 hisher 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 childs 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 hisher 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
Cognitive Behavior Therapy is a talking therapy that will teach children new skills to better cope with hisher 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 childs 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 hisher 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01MH093402-01A1 | NIH | None | httpsreporternihgovquickSearch1R01MH093402-01A1 |