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Completed

NCT Number: NCT01686087

Attaining and Maintaining Wellness in Obsessive-compulsive Disorder

The goal of this study is to understand whether patients with obsessive-compulsive disorder (OCD) on serotonin reuptake inhibitors (SRIs) who receive a type of Cognitive-behavioral therapy called Exposure and Ritual Prevention (EX/RP) can discontinue their medication if they first do well with EX/RP.

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Key information

Conditions

Obsessive Compulsive Disorder Anxiety Disorders Mental Disorders Obsessive-Compulsive Disorder

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York State Psychiatric Institute, New York, United States

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About this study

This study begins with a Preparatory Phase, wherein all eligible participants receive up to 25 sessions of Exposure and Ritual Prevention (EX/RP) therapy. At the end of the Preparatory Phase, those who have achieved wellness (mild to minimal symptoms) enter the Study Phase. Those who do not achieve wellness will not continue in the study and are referred for treatment elsewhere. Those who enter the Study Phase are then assigned by chance to one of two groups. One group will continue on the SRI medication and the other group will discontinue the SRI gradually over 4-6 weeks as it is replaced with a placebo (sugar pill). Neither patients nor study staff will know which group a participant is in. Both groups will continue to receive monthly sessions of EX/RP. The study will examine who has the best response to treatment in this study, including taking blood samples for genetic testing to see whether there are genes that can predict who will or will not benefit from EX/RP.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Preparatory Phase

Inclusion criteria

  • Primary diagnosis of OCD
  • Currently on a stable and adequate dose of a serotonin reuptake inhibitor (i.e., clomipramine, fluoxetine, fluvoxamine, sertraline, paroxetine, citalopram, escitalopram) but still have clinically significant OCD symptoms

Exclusion criteria

  • Comorbid Psychiatric conditions that significantly elevate the risks of study participation (e.g. psychotic disorders, bipolar disorder, evidence of dementia or other cognitive disorder, suicidality)
  • Unstable medical conditions that need attention and would make participation in the study unsafe (e.g., very high blood pressure)
  • Patients who have already had prior adjunctive EX/RP (more than 8 sessions within 2 months) while receiving an adequate SRI trial
  • Patients taking other medications besides an SRI (e.g. antipsychotics, mood stabilizers, other antidepressants besides SRIs)
  • Patients who are pregnant, sexually active and not using contraception, or nursing

Study Phase

Inclusion criteria

  • Those who achieve mild to minimum OCD symptoms from Preparatory Phase will enter the Study Phase

Exclusion criteria

  • All exclusions listed above for Preparatory Phase are exclusions for Study Phase as well
  • Patients who are depressed at the end of the Preparatory phase are excluded from Study Phase

Treatment and study plan

Monthly Booster Sessions of EX/RP

Behavioral

45 minute EXRP booster sessions each month

Visits with MD and independent evaluators

Procedure

All patients will be followed carefully and evaluated by their study doctor and an independent evaluator to assess their symptoms.

Primary outcomes

  1. Obsessive Compulsive Symptom Severity (Y-BOCS)

    Time frame: 6 months

    In study phase, to determine whether those who have achieved wellness with Cognitive Behavioral Therapy who are on medication can maintain wellness when medication is stopped

Secondary outcomes

  1. Depressive severity (HAMD17)

    Time frame: 6 months

    Hamilton Depression Scale (HAMD, 17 item)

  2. Quality of Life (QLESQ-S)

    Time frame: 6 months

    Quality of Life Satisfaction Questionnaire (QLESQ, short form)

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Attaining and Maintaining Wellness in OCD

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Sep 17, 2012
Registry last updated
Mar 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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