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

Discontinuation of Long-term SRIs in Obsessive Compulsive Disorder

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02103621
Enrollment
14
Registered
2014-04-04
Start date
2014-05-31
Completion date
2018-01-31
Last updated
2018-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obsessive Compulsive Disorder

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.

Interventions

BEHAVIORALTaper and Monitoring (TAP-M)

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Butler Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)14 weeks post baseline

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026