Treatment of Obsessive Compulsive Disorder in Children

• ClinicalTrials.gov Identifier: NCT00074815
• Recruitment Status: Completed
• First Posted: December 22, 2003
• Results First Posted: February 11, 2013
• Last Update Posted: July 29, 2014
• Sponsor: Duke University
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Duke University

Study Description

Brief Summary:

This study will determine whether cognitive behavioral therapy delivered by either psychologists or psychiatrists can improve the effectiveness of serotonin reuptake inhibitor treatment in children with obsessive compulsive disorder.

Condition or disease	Intervention/treatment	Phase
Obsessive-Compulsive Disorder	Drug: Serotonin reuptake inhibitors management; Behavioral: Cognitive behavioral therapy by a psychologist; Behavioral: Instructional cognitive behavioral therapy by a psychiatrist	Phase 3

Detailed Description:

The vast majority of children with obsessive compulsive disorder (OCD) are given serotonin reuptake inhibitor (SRI) drugs as initial treatment. However, recommended doses of these medications leave many children with clinically significant residual symptoms. Health care experts typically recommend augmenting SRI treatment with cognitive behavioral therapy (CBT), yet this recommendation is seldom followed. This study will contrast two CBT augmentation strategies to continued medication management alone: CBT administered by a psychologist and instructional CBT (I-CBT)administered by a psychiatrist in the context of ongoing medication management.

All patients in the trial will be eligible to receive a full course of CBT by study end. Participants in this study will be randomly assigned to receive CBT, I-CBT or continued medication management. All participants will continue their SRI treatment for 12 weeks. After the 12-week treatment period, participants who received I-CBT or medication management alone and who remain symptomatic will be given CBT as will participants who are asymptomatic but relapse within 6 months after treatment. Assessments will be conducted at Weeks 0, 4, 8, and 12. Follow-up assessments will be conducted at 3 and 6 months post-treatment.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 124 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Treatment of Pediatric OCD for SRI Partial Responders
• Study Start Date: September 2003
• Actual Primary Completion Date: November 2009
• Actual Study Completion Date: November 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: MedMgmt+CBT; Participants will receive the following interventions: 1)SRI medication management with a psychiatrist plus, 2) cognitive behavioral therapy with a psychologist.	Drug: Serotonin reuptake inhibitors management; Participants are maintained on their optimized dose of SRI for OCD symptoms (see "Other Names" section for specific drugs and dosage ranges). If the participant has been treated with an SRI for at least 9 weeks AND has been at a stable dose for the past 3 weeks (e.g., the dose response curve is flat indicating no further improvement in OCD symptoms) OR the participant did not tolerate a dose increase to the next higher dose OR the participant has been at the maximum allowable dose for 3 weeks, then the participant is considered optimized and will be maintained on that dose. During trial, all participants will be maintained on their SRI dose during acute treatment at a constant dose unless side effects warrant downward adjustment of the SRI.; Other Names: Drug Name with Minimum-Maximum Dosage; Citalopram (Celexa)10-60;; Escitalopram (Lexapro)5-30;; Fluoxetine (Prozac) 10-60;; Fluvoxamine (Luvox)25-300;; Paroxetine (Paxil)10-50;; Paroxetine-CR (Paxil)10-50;; Clomipramine (Anafranil)25-200;; Sertraline (Zoloft) 25-200;; Venlafaxine (Effexor)25-225;; Venlafaxine XR (Effexor)37.5-225; Behavioral: Cognitive behavioral therapy by a psychologist; CBT consists of 14 visits over 12 weeks involving: (1) psychoeducation, (2), cognitive training, (3) mapping OCD, and (4) exposure and ritual prevention (EX/RP). The intervention was adapted from March and Mulle (1998) treatment protocol for pediatric OCD.
Experimental: MedMgmt+I-CBT; Participants will receive the following interventions 1)SRI medication management plus, 2) instructional cognitive behavioral therapy. Both of these will be implemented by the same psychiatrist.	Drug: Serotonin reuptake inhibitors management; Participants are maintained on their optimized dose of SRI for OCD symptoms (see "Other Names" section for specific drugs and dosage ranges). If the participant has been treated with an SRI for at least 9 weeks AND has been at a stable dose for the past 3 weeks (e.g., the dose response curve is flat indicating no further improvement in OCD symptoms) OR the participant did not tolerate a dose increase to the next higher dose OR the participant has been at the maximum allowable dose for 3 weeks, then the participant is considered optimized and will be maintained on that dose. During trial, all participants will be maintained on their SRI dose during acute treatment at a constant dose unless side effects warrant downward adjustment of the SRI.; Other Names: Drug Name with Minimum-Maximum Dosage; Citalopram (Celexa)10-60;; Escitalopram (Lexapro)5-30;; Fluoxetine (Prozac) 10-60;; Fluvoxamine (Luvox)25-300;; Paroxetine (Paxil)10-50;; Paroxetine-CR (Paxil)10-50;; Clomipramine (Anafranil)25-200;; Sertraline (Zoloft) 25-200;; Venlafaxine (Effexor)25-225;; Venlafaxine XR (Effexor)37.5-225; Behavioral: Instructional cognitive behavioral therapy by a psychiatrist; The psychiatrist who manages medication will also provide instructions in the CBT procedures that have been found to help reduce OCD symptoms, namely EX/RP. MM+I-CBT was constructed as a single-doctor "best practice" treatment with three primary goals: (1) inclusion of the main psychoeducational and EX/RP components of the full CBT protocol; (2) feasibility of training psychiatrists to perform the CBT component of MM+I-CBT; (3) integration with protocol medication management visits; and (4) feasibility of implementation with the constraints of a busy practice oriented primarily toward pharmacotherapy.
Active Comparator: MedMgmt Only; Participants will receive the intervention SRI medication management with a psychiatrist	Drug: Serotonin reuptake inhibitors management; Participants are maintained on their optimized dose of SRI for OCD symptoms (see "Other Names" section for specific drugs and dosage ranges). If the participant has been treated with an SRI for at least 9 weeks AND has been at a stable dose for the past 3 weeks (e.g., the dose response curve is flat indicating no further improvement in OCD symptoms) OR the participant did not tolerate a dose increase to the next higher dose OR the participant has been at the maximum allowable dose for 3 weeks, then the participant is considered optimized and will be maintained on that dose. During trial, all participants will be maintained on their SRI dose during acute treatment at a constant dose unless side effects warrant downward adjustment of the SRI.; Other Names: Drug Name with Minimum-Maximum Dosage; Citalopram (Celexa)10-60;; Escitalopram (Lexapro)5-30;; Fluoxetine (Prozac) 10-60;; Fluvoxamine (Luvox)25-300;; Paroxetine (Paxil)10-50;; Paroxetine-CR (Paxil)10-50;; Clomipramine (Anafranil)25-200;; Sertraline (Zoloft) 25-200;; Venlafaxine (Effexor)25-225;; Venlafaxine XR (Effexor)37.5-225;

Outcome Measures

Primary Outcome Measures :

1. Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) [ Time Frame: Measured at baseline and Week 12. ]

   OCD symptom severity was measured using the CY-BOCS, an interviewer-rated instrument that assess obsessions and compulsions separately on time consumed, distress, interference, degree of resistance, and control; it yields separate severity scores for obsessions and for compulsions (0 - 20), and a composite symptom severity score (0 to 40).

   Consistent with signal detection analyses examining the optimal criterion for treatment response, a CY-BOCS reduction of 30% or more from baseline to week 12 was used as the criterion for RESPONSE and was the primary dichotomous outcome measure.

Secondary Outcome Measures :

1. Child Obsessive -Compulsive Impact Scale (COIS) [ Time Frame: Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up ]
2. Child Depression Inventory [ Time Frame: Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up ]
3. Pediatric Adverse Event Rating Scale (PAERS) [ Time Frame: Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up ]

Eligibility Criteria

• Ages Eligible for Study: 7 Years to 17 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• DSM-IV Diagnosis of obsessive compulsive disorder
• CYBOCS total score greater than 16

Exclusion Criteria:

• Other primary or co-primary psychiatric disorder
• Pervasive developmental disorder or disorders, including Asperger's Syndrome
• Thought disorder
• Prior failed trial of cognitive-behavioral therapy
• Has pediatric autoimmune neuropsychiatric disorders associated with streptococcus (PANDAS) or maintenance antibiotic for obsessive-compulsive disorder
• Mental retardation
• Pregnancy

Contacts and Locations

Locations

United States, North Carolina

Duke Child and Family Study Center

Durham, North Carolina, United States, 27705

United States, Pennsylvania

University of Pennsylvania, The Center for the Treatment and Study of Anxiety

Philadelphia, Pennsylvania, United States, 19104

United States, Rhode Island

Rhode Island Hospital

Providence, Rhode Island, United States, 02903

Sponsors and Collaborators

Duke University

National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: John S March, MD MPH; Duke University

More Information

Publications of Results:

Franklin ME, Sapyta J, Freeman JB, Khanna M, Compton S, Almirall D, Moore P, Choate-Summers M, Garcia A, Edson AL, Foa EB, March JS. Cognitive behavior therapy augmentation of pharmacotherapy in pediatric obsessive-compulsive disorder: the Pediatric OCD Treatment Study II (POTS II) randomized controlled trial. JAMA. 2011 Sep 21;306(11):1224-32. doi: 10.1001/jama.2011.1344. Erratum in: JAMA. 2012 Apr 25;307(16):1694.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Conelea CA, Selles RR, Benito KG, Walther MM, Machan JT, Garcia AM, Sapyta J, Morris S, Franklin M, Freeman JB. Secondary outcomes from the pediatric obsessive compulsive disorder treatment study II. J Psychiatr Res. 2017 Sep;92:94-100. doi: 10.1016/j.jpsychires.2017.04.001. Epub 2017 Apr 7.

Conelea CA, Walther MR, Freeman JB, Garcia AM, Sapyta J, Khanna M, Franklin M. Tic-related obsessive-compulsive disorder (OCD): phenomenology and treatment outcome in the Pediatric OCD Treatment Study II. J Am Acad Child Adolesc Psychiatry. 2014 Dec;53(12):1308-16. doi: 10.1016/j.jaac.2014.09.014. Epub 2014 Oct 2.

Freeman JB, Choate-Summers ML, Garcia AM, Moore PS, Sapyta JJ, Khanna MS, March JS, Foa EB, Franklin ME. The Pediatric Obsessive-Compulsive Disorder Treatment Study II: rationale, design and methods. Child Adolesc Psychiatry Ment Health. 2009 Jan 30;3(1):4. doi: 10.1186/1753-2000-3-4.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT00074815
• Other Study ID Numbers: Pro00008097; R01MH055121 ( U.S. NIH Grant/Contract ); DSIR 84-CTM
• First Posted: December 22, 2003
• Results First Posted: February 11, 2013
• Last Update Posted: July 29, 2014
• Last Verified: November 2012

Keywords provided by Duke University:

Child; Adolescent

Additional relevant MeSH terms:

Compulsive Personality Disorder; Obsessive-Compulsive Disorder; Personality Disorders; Mental Disorders; Anxiety Disorders; Paroxetine; Venlafaxine Hydrochloride; Serotonin Uptake Inhibitors; Serotonin; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs; Antidepressive Agents, Second-Generation; Antidepressive Agents; Psychotropic Drugs; Cytochrome P-450 CYP2D6 Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Enzyme Inhibitors; Serotonin Receptor Agonists; Serotonin and Noradrenaline Reuptake Inhibitors