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

NCT02103621 | Completed DMC

• 2 other identifiers: 1402-0021R21MH100444-01A1
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive Compulsive Disorder

Outcome Measures

Primary Outcomes (1)

• Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

  14 weeks post baseline

Study Arms (2)

Unifed Protocol (UP) for Discontinuation

EXPERIMENTAL

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)

Taper and Monitoring (TAP-M)

ACTIVE COMPARATOR

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)

Interventions

Unified Protocol (UP) BEHAVIORAL

Unifed Protocol (UP) for Discontinuation

Taper and Monitoring (TAP-M) BEHAVIORAL

Taper and Monitoring (TAP-M)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Clinically significant suicidality or a suicide attempt within the past year
• Presence of any clinical features warranting a higher level of care (partial or inpatient hospitalization)
• Current or recent (past 6 months) alcohol or drug dependence or abuse
• Current or past psychotic disorder or bipolar disorder
• 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)
• History of severe OCD (YBOCS ≥ 28)
• Prior adverse experience with SRI discontinuation
• Primary compulsive hoarding
• Cognitive impairment that would interfere with study participation
• Concomitant psychosocial treatment w/ proven efficacy in the treatment of OCD
• Previous adequate trial of exposure-based treatment (e.g., history of 12 or more sessions) in past 5 years
• Use of non-SRI psychotropic medications for OCD in the 3 months prior to enrollment.

Sponsors & Collaborators

• Butler Hospital: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Christina L Boisseau, Ph.D.

  Butler Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2014
• First Posted: April 4, 2014
• Study Start: May 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: January 1, 2018
• Last Updated: June 14, 2018

Record last verified: 2018-06

Locations

US (1)