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Open/Aftercare Treatment for Participants Diagnosed With Obsessive Compulsive Disorder

Sponsor
Stanford University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03511534
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
107.3
Anticipated Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to provide participants diagnosed with obsessive compulsive disorder (OCD) and completed one of the active study protocols at the Rodriguez Lab, with open/aftercare treatment.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Psychotherapy
  • Other: Pharmacotherapy
 N/A

Detailed Description

After completing one of the active clinical studies participants have the option to enroll in this protocol that offers open treatment.

The goal is to compare two forms of current standard treatments, psychotherapy vs pharmacotherapy.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Participants will choose to enter the psychotherapy or pharmacotherapy arm.Participants will choose to enter the psychotherapy or pharmacotherapy arm.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Open/Aftercare Treatment for Participants Diagnosed With Obsessive Compulsive Disorder
Actual Study Start Date :
Jun 23, 2017
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Jun 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Psychotherapy

Participants will receive evidenced based psychotherapy by a trained psychologist

Behavioral: Psychotherapy
Evidenced based psychotherapy by a trained psychologist
Active Comparator: Pharmacotherapy

Participants will receive pharmacotherapy by a psychiatrist

Other: Pharmacotherapy
Pharmacotherapy by a psychiatrist

Outcome Measures

Primary Outcome Measures

  1. Improvement in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS) [Up to 14 weeks]

    Improvement in OCD severity is measured by the YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response is defined as at least a 35% reduction on the YBOCS.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Ability to speak and understand English

  2. Capacity to consent (e.g. as determined by assessing the patient's understanding of the risks, benefits, and procedures of the study)

  3. Completed an active study protocol at the Rodriguez Lab at Stanford University

Exclusion Criteria:

  1. Children younger than 18

  2. Active suicidality

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stanford University Stanford California United States 94305

Sponsors and Collaborators

  • Stanford University

Investigators

  • Principal Investigator: Carolyn Rodriguez, MD, PhD, Assistant Professor, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Carolyn Rodriguez, Assistant Professor, Stanford University
ClinicalTrials.gov Identifier:
NCT03511534
Other Study ID Numbers:
  • 41165
First Posted:
Apr 30, 2018
Last Update Posted:
May 14, 2020
Last Verified:
May 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Carolyn Rodriguez, Assistant Professor, Stanford University
treatment, psychotherapy, pharmacotherapy
Additional relevant MeSH terms:
Compulsive Personality Disorder
Obsessive-Compulsive Disorder

Study Results

No Results Posted as of May 14, 2020