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

This study is currently recruiting participants.
Verified November 2012 by Massachusetts General Hospital
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
University of South Florida
Information provided by (Responsible Party):
Daniel A. Geller, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01404208
First received: July 25, 2011
Last updated: November 14, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Obsessive-Compulsive Disorder
 Drug: D-Cycloserine
Drug: Placebo

Study Type: Interventional
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

Resource links provided by NLM:

Drug Information available for: Cycloserine
U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Clinical Global Impression-Improvement [ Time Frame: Change from Drug Randomization Point to Follow Up (34 weeks) ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: July 2011
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: D-Cycloserine Drug: 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 Drug: Placebo
Sugar pill

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01404208

Contacts
Contact: Kesley A Ramsey, B.S. 617-726-5578 karamsey@partners.org
Contact: Abigail Stark, B.A. 617-726-5527 amstark@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Kesley A Ramsey, B.S.     617-726-5578     karamsey@partners.org    
Contact: Abigail Stark, B.A.     617-726-5527     amstark@partners.org    
Principal Investigator: Daniel A Geller, M.D.            
Sub-Investigator: Sabine Wilhelm, Ph.D.            
Sponsors and Collaborators
Massachusetts General Hospital
National Institute of Mental Health (NIMH)
University of South Florida
Investigators
Principal Investigator: Daniel A Geller, M.D. Massachusetts General Hospital
  More Information

Additional Information:
The OCD and Related Disorder Program at Massachusetts General Hospital  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Daniel A. Geller, M.D., Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01404208     History of Changes
Other Study ID Numbers: 2011P000875, 1R01MH093402-01A1
Study First Received: July 25, 2011
Last Updated: November 14, 2012
Health Authority: United States: Federal Government
United States: Institutional Review Board

Additional relevant MeSH terms:
Obsessive-Compulsive Disorder
Compulsive Personality Disorder
Anxiety Disorders
Mental Disorders
Personality Disorders
Cycloserine
Anti-Infective Agents, Urinary
Anti-Infective Agents
 Therapeutic Uses
Pharmacologic Actions
Renal Agents
Antibiotics, Antitubercular
Anti-Bacterial Agents
Antitubercular Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013