NCT00074815

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2003

Longer than P75 for phase_3

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 22, 2003

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

February 11, 2013

Completed
Last Updated

July 29, 2014

Status Verified

November 1, 2012

Enrollment Period

6.2 years

First QC Date

December 19, 2003

Results QC Date

November 15, 2012

Last Update Submit

July 23, 2014

Conditions

Obsessive-Compulsive Disorder

Keywords

ChildAdolescent

Outcome Measures

Primary Outcomes (1)

  • Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)

    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.

    Measured at baseline and Week 12.

Secondary Outcomes (3)

  • Child Obsessive -Compulsive Impact Scale (COIS)

    Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up

  • Child Depression Inventory

    Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up

  • Pediatric Adverse Event Rating Scale (PAERS)

    Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up

Study Arms (3)

MedMgmt+CBT

EXPERIMENTAL

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 managementBehavioral: Cognitive behavioral therapy by a psychologist

MedMgmt+I-CBT

EXPERIMENTAL

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 managementBehavioral: Instructional cognitive behavioral therapy by a psychiatrist

MedMgmt Only

ACTIVE COMPARATOR

Participants will receive the intervention SRI medication management with a psychiatrist

Drug: Serotonin reuptake inhibitors management

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.

Also known as: 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;
MedMgmt OnlyMedMgmt+CBTMedMgmt+I-CBT
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.

MedMgmt+CBT
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.

MedMgmt+I-CBT

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Duke Child and Family Study Center

Durham, North Carolina, 27705, United States

Location

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

Philadelphia, Pennsylvania, 19104, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (4)

  • 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.

    PMID: 21934055RESULT

  • 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.

    PMID: 28412602DERIVED

  • 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.

    PMID: 25457929DERIVED

  • 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.

    PMID: 19183470DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

CitalopramEscitalopramFluoxetineFluvoxamineParoxetineClomipramineSertralineVenlafaxine Hydrochloride

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsOximesHydroxylaminesPiperidinesHeterocyclic Compounds, 1-RingDibenzazepinesHeterocyclic Compounds, 3-Ring1-NaphthylamineNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsCyclohexanolsHexanolsFatty AlcoholsAlcoholsPhenethylaminesEthylaminesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicLipids

Results Point of Contact

Title
Jeffrey Sapyta, PhD
Organization
Duke University School of Medicine
jeffrey.sapyta@duke.edu
919-668-0069

Study Officials

  • John S March, MD MPH

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2003

First Posted

December 22, 2003

Study Start

September 1, 2003

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

July 29, 2014

Results First Posted

February 11, 2013

Record last verified: 2012-11

Locations

US(3)