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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01404208
First Posted: July 27, 2011
Last Update Posted: March 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute of Mental Health (NIMH)
University of South Florida
Information provided by (Responsible Party):
Daniel A. Geller, Massachusetts General Hospital
  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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 2/2 D-Cycloserine Augmentation of CBT for Pediatric OCD

Resource links provided by NLM:


Further study details as provided by Daniel A. Geller, Massachusetts General Hospital:

Primary Outcome Measures:
  • Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) [ Time Frame: Change from Score at Randomization to Post Treatment ]
    The CY-BOCS is a measure of severity of OCD symptoms, including interference, time spent on thoughts or behaviors, distress, resistance, etc. The CY-BOCS is measured from 0 to 40, with larger values indicating more severe symptoms. Our outcome measure was the difference between the post treatment and randomization scores. When those values are negative, it indicates a reduction in symptom severity.


Secondary Outcome Measures:
  • Clinical Global Impression-Severity (CGI-Severity) [ Time Frame: Change from Randomization Point to Post Treatment ]
    The Clinical Global Impression-Severity is a 7-point clinician rating of illness severity, with a score of 0 indicating no illness and a score of 6 indicating extremely severe symptoms. Because the secondary outcome was the change in score from randomization to post treatment, a more negative score indicates a greater reduction in symptom severity.


Enrollment: 206
Study Start Date: July 2011
Study Completion Date: December 2016
Primary Completion Date: September 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01404208


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
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:
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 ( U.S. NIH Grant/Contract )
First Submitted: July 25, 2011
First Posted: July 27, 2011
Results First Submitted: September 30, 2016
Results First Posted: February 27, 2017
Last Update Posted: March 28, 2017
Last Verified: February 2017

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