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

Discontinuation of Long-term SRIs in Obsessive Compulsive Disorder

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.

Study Overview

• Status: Completed
• Conditions: Obsessive Compulsive Disorder
• Intervention / Treatment: Behavioral: Unified Protocol (UP); Behavioral: Taper and Monitoring (TAP-M)

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Butler Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Unifed Protocol (UP) for Discontinuation; 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.	Behavioral: Unified Protocol (UP)
ACTIVE_COMPARATOR: 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.	Behavioral: Taper and Monitoring (TAP-M)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)	14 weeks post baseline

Collaborators and Investigators

• Sponsor: Butler Hospital
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Christina L Boisseau, Ph.D., Butler Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (ACTUAL): September 1, 2017
• Study Completion (ACTUAL): January 1, 2018

Study Registration Dates

• First Submitted: April 1, 2014
• First Submitted That Met QC Criteria: April 1, 2014
• First Posted (ESTIMATE): April 4, 2014

Study Record Updates

• Last Update Posted (ACTUAL): June 14, 2018
• Last Update Submitted That Met QC Criteria: June 13, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: 1402-002 (OTHER: Butler Hospital); 1R21MH100444-01A1 (NIH)