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Completed

NCT Number: NCT02103621

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

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.

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Key information

Conditions

Obsessive Compulsive Disorder Anxiety Disorders Mental Disorders Obsessive-Compulsive Disorder

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Butler Hospital

Providence, Rhode Island, 02906, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 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

Exclusion criteria

  • 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.

Treatment and study plan

Unified Protocol (UP)

Behavioral

Taper and Monitoring (TAP-M)

Behavioral

Primary outcomes

  1. Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

    Time frame: 14 weeks post baseline

Sponsors and collaborators

Lead sponsor

Butler Hospital

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Discontinuation of Long-term SRIs in Obsessive Compulsive Disorder

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Apr 4, 2014
Registry last updated
Jun 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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