Obsessive-Compulsive DisorderPhase 3NCT00074815
Treatment of Obsessive Compulsive Disorder in Children
A Phase 3 study testing Serotonin reuptake inhibitors management, Cognitive behavioral therapy by a psychologist and Instructional cognitive behavioral therapy by a psychiatrist in people with Obsessive-Compulsive Disorder, run by Duke University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Serotonin reuptake inhibitors management, Cognitive behavioral therapy by a psychologist and Instructional cognitive behavioral therapy by a psychiatrist
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2003to Nov 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- DSM-IV Diagnosis of obsessive compulsive disorder
- CYBOCS total score greater than 16
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Duke Child and Family Study Center
Durham, North Carolina, 27705
University of Pennsylvania, The Center for the Treatment and Study of Anxiety
Philadelphia, Pennsylvania, 19104
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
Official title: Treatment of Pediatric OCD for SRI Partial Responders
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.
Read the 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.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Serotonin reuptake inhibitors management, Cognitive behavioral therapy by a psychologist, Instructional cognitive behavioral therapy by a psychiatrist
- Keywords
- Child, Adolescent
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serotonin reuptake inhibitors managementDrug
Also called Drug Name with Minimum-Maximum Dosage, Citalopram (Celexa)10-60;, Escitalopram (Lexapro)5-30;, Fluoxetine (Prozac) 10-60;
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 psychologistBehavioural
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 psychiatristBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| MedMgmt+CBT | Experimental | Participants will receive the following interventions: 1)SRI medication management with a psychiatrist plus, 2) cognitive behavioral therapy with a psychologist. Receives: Drug: Serotonin reuptake inhibitors management; Behavioral: 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. Receives: Drug: Serotonin reuptake inhibitors management; Behavioral: Instructional cognitive behavioral therapy by a psychiatrist |
| MedMgmt Only | Active comparator | Participants will receive the intervention SRI medication management with a psychiatrist Receives: Drug: Serotonin reuptake inhibitors management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at baseline and Week 12.
Secondary outcomes (3)
Child Obsessive -Compulsive Impact Scale (COIS)
Measured: Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up
Child Depression Inventory
Measured: Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up
Pediatric Adverse Event Rating Scale (PAERS)
Measured: Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2003 (estimated)
- Study startSep 2003
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- John S March, MD MPH, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00074815
- Sponsor's protocol ID
- Pro00008097
- Other IDs
- R01MH055121, DSIR 84-CTM
- Status last verified
- Nov 2012
- First submitted
- 19 Dec 2003
- Last updated
- 29 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 21934055Conelea 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.
PubMed 28412602Conelea 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.
PubMed 25457929Freeman 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.
PubMed 19183470
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Pediatric OCD for SRI Partial Responders
- ClinicalTrials.gov ID
- NCT00074815
- Acronym / sponsor ID
- Pro00008097
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Child, Adolescent
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2003
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 22 Dec 2003 (estimated)
- Results
- Posted 11 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MedMgmt+CBT | Experimental | Drug: Serotonin reuptake inhibitors management, Behavioral: Cognitive behavioral therapy by a psychologistParticipants will receive the following interventions: 1)SRI medication management with a psychiatrist plus, 2) cognitive behavioral therapy with a psychologist. |
| MedMgmt+I-CBT | Experimental | Drug: Serotonin reuptake inhibitors management, Behavioral: Instructional cognitive behavioral therapy by a psychiatristParticipants 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. |
| MedMgmt Only | Active comparator | Drug: Serotonin reuptake inhibitors managementParticipants will receive the intervention SRI medication management with a psychiatrist |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- DSM-IV Diagnosis of obsessive compulsive disorder
- CYBOCS total score greater than 16
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serotonin reuptake inhibitors managementAlso: Drug Name with Minimum-Maximum Dosage, Citalopram (Celexa)10-60;, Escitalopram (Lexapro)5-30;, Fluoxetine (Prozac) 10-60;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. | Drug | MedMgmt Only, MedMgmt+CBT, MedMgmt+I-CBT |
| Cognitive behavioral therapy by a psychologistCBT 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. | Behavioural | MedMgmt+CBT |
| Instructional cognitive behavioral therapy by a psychiatristThe 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. | Behavioural | MedMgmt+I-CBT |
Primary outcome
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.
3 secondary outcomes
Child Obsessive -Compulsive Impact Scale (COIS)
Time frame: Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up
Child Depression Inventory
Time frame: Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up
Pediatric Adverse Event Rating Scale (PAERS)
Time frame: Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21934055Franklin 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.
- Derived from this study: PubMed 28412602Conelea 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.
- Derived from this study: PubMed 25457929Conelea 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.
- Derived from this study: PubMed 19183470Freeman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John S March, MD MPH principal investigator
Duke University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Serotonin reuptake inhibitors management, Cognitive behavioral therapy by a psychologist and Instructional cognitive behavioral therapy by a psychiatrist in people with Obsessive-Compulsive Disorder, run by Duke University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) (time frame: Measured at baseline and Week 12.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00074815, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2014.