Attaining and Maintaining Wellness in Obsessive-compulsive Disorder

Obsessive Compulsive Disorder Clinical Trial

Official title:

Attaining and Maintaining Wellness in OCD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01686087
• Other study ID #: 6628
• Secondary ID: 2R01MH045436-18
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: July 2018

Study information

• Verified date: March 2019
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: July 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Obsessive Compulsive Disorder
• Obsessive-Compulsive Disorder

Intervention

Behavioral:
• Monthly Booster Sessions of EX/RP
45 minute EXRP booster sessions each month

Procedure:
• Visits with MD and independent evaluators
All patients will be followed carefully and evaluated by their study doctor and an independent evaluator to assess their symptoms.

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York
United States	University of Pennsylvania Center for the Treatment and Study of Anxiety	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Obsessive Compulsive Symptom Severity (Y-BOCS)	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	6 months
Secondary	Depressive severity (HAMD17)	Hamilton Depression Scale (HAMD, 17 item)	6 months
Secondary	Quality of Life (QLESQ-S)	Quality of Life Satisfaction Questionnaire (QLESQ, short form)	6 months

External Links

•   For more information about the treatment study visit our webpage.