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

Obsessive Compulsive Disorder Clinical Trial

Official title:

Discontinuation of Long-term SRIs in Obsessive Compulsive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02103621
• Other study ID #: 1402-002
• Secondary ID: 1R21MH100444-01A
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: January 2018

Study information

• Verified date: June 2018
• Source: Butler Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Obsessive Compulsive Disorder
• Obsessive-Compulsive Disorder

Intervention

Behavioral:
• Unified Protocol (UP)

• Taper and Monitoring (TAP-M)

Locations

Country	Name	City	State
United States	Butler Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Butler Hospital	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Yale-Brown Obsessive Compulsive Scale (Y-BOCS)		14 weeks post baseline