CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 124 enrolled
Drug / intervention
Serotonin reuptake inhibitors management +2 moredrug
Likely dose
Not stated in record
Key inclusion· 2
  • DSM-IV diagnosis of obsessive-compulsive disorder
  • CYBOCS total score greater than 16 (moderate-to-severe OCD symptoms)
Key exclusion· 7
  • 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

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00074815
NCT00074815Phase 3Completed

Treatment of Pediatric OCD for SRI Partial Responders

Duke University·interventional·Posted Dec 22, 2003·Updated Jul 29, 2014

In Brief

A Phase 3 clinical trial evaluating Serotonin reuptake inhibitors management, Cognitive behavioral therapy by a psychologist, and 1 other intervention for Obsessive-Compulsive Disorder. Completed, enrolled 124 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 22, 2003
Enrollment StartSep 1, 2003
Primary CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 22.5 years ago

Interventions

Serotonin reuptake inhibitors managementdrug

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.

Cognitive behavioral therapy by a psychologistbehavioral

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.

Instructional cognitive behavioral therapy by a psychiatristbehavioral

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.