Assisting Obsessive Compulsive Disorder (OCD) Patients With Discontinuing Long-term Serotonin Reuptake Inhibitors (SRIs)

Not Applicable

Completed

• Conditions: Obsessive Compulsive Disorder
• Interventions: Behavioral: Taper and Monitoring (TAP-M); Behavioral: Unified Protocol (UP)

• Registration Number: NCT02103621
• Lead Sponsor: Butler Hospital

Brief Summary

This study will address questions of fundamental clinical significance including: (1) whether OCD patients maintained on long term SRIs can be discontinued without symptom exacerbation, (2) whether trans-diagnostic cognitive-behavioral treatment will reduce worsening following discontinuation compared to Taper and Monitoring, and (3) whether predictors of successful SRI discontinuation can be identified.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-01
• Study First Submitted QC: 2014-04-01
• Study First Posted: 2014-04-04
• Study Start: 2014-05
• Primary Completion: 2017-09
• Study Completion: 2018-01
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-13
• Last Update Posted: 2018-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

1. 18 or older
2. Presence of mild to moderate OCD symptoms
3. Patient's treating clinician agrees that SRI discontinuation is clinically appropriate
4. Adequate trial of SRI (≥10 weeks) in the current treatment episode
5. Maintenance on SRI dose that has not increased due to significant clinical worsening in the two years prior to enrollment
6. English speaking

Exclusion Criteria

1. Clinically significant suicidality or a suicide attempt within the past year
2. Presence of any clinical features warranting a higher level of care (partial or inpatient hospitalization)
3. Current or recent (past 6 months) alcohol or drug dependence or abuse
4. Current or past psychotic disorder or bipolar disorder
5. Moderate to severe depression, as indicated by a Hamilton Rating Scale for Depression (HRSD) (17-item) ≥ 14 or recent major depressive episode (past 6 months)
6. History of severe OCD (YBOCS ≥ 28)
7. Prior adverse experience with SRI discontinuation
8. Primary compulsive hoarding
9. Cognitive impairment that would interfere with study participation
10. Concomitant psychosocial treatment w/ proven efficacy in the treatment of OCD
11. Previous adequate trial of exposure-based treatment (e.g., history of 12 or more sessions) in past 5 years
12. Use of non-SRI psychotropic medications for OCD in the 3 months prior to enrollment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Taper and Monitoring (TAP-M)	Taper and Monitoring (TAP-M)	Taper and Monitoring (TAP-M) is delivered in biweekly individual sessions over 14 weeks, with booster sessions at two, four, and eight weeks thereafter. TAP-M consists of assessment and monitoring. Participants will also receive 7 biweekly medication management sessions over 14 weeks with a study psychiatrist to facilitate gradual taper of SRI medication.
Unifed Protocol (UP) for Discontinuation	Unified Protocol (UP)	Unified Protocol (UP) for Discontinuation is delivered in 14 weekly individual sessions of 45-60 minutes followed by 3 booster sessions scheduled at two, four and eight weeks thereafter. The UP is a cognitive behavioral treatment that focuses on increasing emotional awareness and cognitive flexibility, preventing behavioral and emotional avoidance, and situational and interoceptive emotion-focused exposure. Participants will also receive 7 biweekly medication management sessions over 14 weeks with a study psychiatrist to facilitate gradual taper of SRI medication.

Primary Outcome Measures

Name	Time	Method
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)	14 weeks post baseline

Trial Locations

Locations (1)

Butler Hospital; 🇺🇸 Providence, Rhode Island, United States