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Obsessive-Compulsive DisorderNCT00389493

Risperidone or Cognitive-Behavioral Therapy for Improving Medication Treatment for Obsessive-compulsive Disorder

A study testing Risperidone and Exposure/ritual prevention therapy (EX/RP) in people with Obsessive-Compulsive Disorder, run by New York State Psychiatric Institute at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will compare the short- and long-term effectiveness of two common therapies in improving serotonin reuptake inhibitor treatment in people with obsessive-compulsive disorder. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Obsessive-Compulsive Disorder
What is being tested?
Risperidone and Exposure/ritual prevention therapy (EX/RP)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
2 sitesUnited States
Study dates
Oct 2006to Dec 2012
Phase
Interventional
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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Primary diagnosis of OCD
  • Currently on a stable and adequate dose of an SRI
  • Sufficient severity of symptoms to warrant additional augmentation treatment

Who cannot join

  • Medical or psychiatric conditions that would make participation in the study unsafe
  • Currently receiving psychotherapy elsewhere at the time of study entry
  • Previously (within 12 weeks prior to study entry) attended 8 or more sessions of EX/RP within a 2-month period or received at least 4 weeks of antipsychotic augmentation while on an adequate SRI dose
  • Currently being treated with an SRI for the first time and has not yet responded, but has not tried another SRI

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • New York State Psychiatric Institute

    New York, New York, 10032

  • University of Pennsylvania Center for the Treatment and Study of Anxiety

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Maximizing Treatment Outcome in OCD

This study will compare the short- and long-term effectiveness of two common therapies in improving serotonin reuptake inhibitor treatment in people with obsessive-compulsive disorder.

Read the detailed description

Obsessive-compulsive disorder (OCD) is a common psychiatric illness. People with OCD experience unwelcome thoughts, known as obsessions, and feel compelled to perform repetitive behaviors, or compulsions. Impairment due to OCD symptoms ranges from mild to severe, and sometimes can be disabling. The only medications proven effective for OCD are serotonin reuptake inhibitors (SRIs), but even with SRI treatment, most patients continue to experience significant OCD symptoms, impaired functioning, and diminished quality of life. Cognitive-behavioral therapy (CBT), a talking therapy that focuses on altering a person's thoughts and behaviors, and the medication risperidone have both been commonly used for augmenting SRI treatment for OCD. This study will compare the short- and long-term effectiveness of exposure and ritual prevention (EX/RP), a type of CBT, and risperidone in augmenting SRI treatment in people with OCD.

Participants in this double-blind study will be randomly assigned to receive EX/RP, risperidone, or placebo in conjunction with their regular SRI medication. All participants will remain on their regular SRI at a stable dose. During the first 2 months of the study, participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response. Participants assigned to risperidone or placebo will meet with a psychiatrist once every 1 to 2 weeks. At the end of 8 weeks, all participants' OCD symptom severity will be assessed. During this time, participants who have responded to treatment will continue receiving the same treatment for an additional 24 weeks. Participants assigned to EX/RP will meet with a therapist no more than 15 times total, and participants receiving risperidone or placebo will meet with a psychiatrist once every 4 weeks. Outcomes will be reassessed at study completion.

Ortho McNeil Janssen Scientific Affairs, LLC are providing medication and placebos for this study.

For information on a related study, please follow this link:

http://clinicaltrials.gov/show/NCT00045903

Being tested
Risperidone, Exposure/ritual prevention therapy (EX/RP), Placebo
Keywords
OCD, Augmentation, Antipsychotics, Cognitive-Behavioral Therapy
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.

  • RisperidoneDrug

    Also called Risperdal

    Dosage of 0.5 mg to 4.0 mg per day as tolerated

  • Exposure/ritual prevention therapy (EX/RP)Behavioural

    Also called EX/RP

    EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response.

  • PlaceboDrug

    Also called PBO

    Placebo capsules will be identical in appearance to those of risperidone.

Study groups in NCT00389493
Study groupRoleWhat they receive
1Active comparatorParticipants will receive treatment with risperidone
Receives: Drug: Risperidone
2Active comparatorParticipants will receive exposure and ritual prevention therapy (EX/RP)
Receives: Behavioral: Exposure/ritual prevention therapy (EX/RP)
3Placebo comparatorParticipants will receive treatment with the placebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Score on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

    Y-BOCS ranges from 0-40, with 0 meaning no symptoms and higher numbers meaning greater symptom severity

    Measured: Week 0 and Week 8

Secondary outcomes (4)

  1. Social Adjustment Scale-SR

    SAS-SR yields a mean score between 1 and 5; the higher the score, the more severe the social adjustment problems

    Measured: Week 0 and Week 8

  2. Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form

    QLESQ ranges from 14-70, with higher scores meaning more enjoyment and satisfaction with quality of life

    Measured: Week 0 and Week 8

  3. Hamilton Depression Rating Scale (Ham-D)

    Ham-D ranges from 0=no symptoms to 52 with higher numbers indicating more severe depression

    Measured: Week 0 and Week 8

  4. Brown Assessment of Beliefs (BABS)

    Scale ranges from 0 to 24 where 0 is "beliefs are false" and 24 is "convinced beliefs = reality"

    Measured: Week 0 and Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2006 (estimated)
  2. Study startOct 2006
  3. Primary completionJun 2012
  4. Study completionDec 2012

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00389493
Sponsor's protocol ID
#5188/#6258R
Other IDs
R01MH045436-02, DSIR 83-ATAS, R01MH045436, R01MH045404
Status last verified
Oct 2013
First submitted
16 Oct 2006
Last updated
25 Apr 2014
Data monitoring committee
Yes

Publications

  • Simpson HB, Foa EB, Liebowitz MR, Huppert JD, Cahill S, Maher MJ, McLean CP, Bender J Jr, Marcus SM, Williams MT, Weaver J, Vermes D, Van Meter PE, Rodriguez CI, Powers M, Pinto A, Imms P, Hahn CG, Campeas R. Cognitive-behavioral therapy vs risperidone for augmenting serotonin reuptake inhibitors in obsessive-compulsive disorder: a randomized clinical trial. JAMA Psychiatry. 2013 Nov;70(11):1190-9. doi: 10.1001/jamapsychiatry.2013.1932.

    PubMed 24026523

  • McLean CP, Zandberg LJ, Van Meter PE, Carpenter JK, Simpson HB, Foa EB. Exposure and response prevention helps adults with obsessive-compulsive disorder who do not respond to pharmacological augmentation strategies. J Clin Psychiatry. 2015 Dec;76(12):1653-7. doi: 10.4088/JCP.14m09513.

    PubMed 26613263

  • Foa EB, Simpson HB, Rosenfield D, Liebowitz MR, Cahill SP, Huppert JD, Bender J Jr, McLean CP, Maher MJ, Campeas R, Hahn CG, Imms P, Pinto A, Powers MB, Rodriguez CI, Van Meter PE, Vermes D, Williams MT. Six-month outcomes from a randomized trial augmenting serotonin reuptake inhibitors with exposure and response prevention or risperidone in adults with obsessive-compulsive disorder. J Clin Psychiatry. 2015 Apr;76(4):440-6. doi: 10.4088/JCP.14m09044.

    PubMed 25375780

  • Farris SG, McLean CP, Van Meter PE, Simpson HB, Foa EB. Treatment response, symptom remission, and wellness in obsessive-compulsive disorder. J Clin Psychiatry. 2013 Jul;74(7):685-90. doi: 10.4088/JCP.12m07789.

    PubMed 23945445

Questions about this trial

What is this clinical trial studying?

A study testing Risperidone and Exposure/ritual prevention therapy (EX/RP) in people with Obsessive-Compulsive Disorder, run by New York State Psychiatric Institute at 2 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 3 inclusion and 4 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 25 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Apr 2014). 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?

Score on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) (time frame: Week 0 and Week 8). 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 NCT00389493, 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 25 Apr 2014; AzTrials last refreshed its copy on 30 Oct 2026.

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