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Open/Aftercare Treatment for Participants Diagnosed With Obsessive Compulsive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03511534
Recruitment Status : Recruiting
First Posted : April 30, 2018
Last Update Posted : May 14, 2020
Sponsor:
Information provided by (Responsible Party):
Carolyn Rodriguez, Stanford University

Study Description
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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
OCD Behavioral: Psychotherapy Other: Pharmacotherapy Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: 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 : June 23, 2017
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : June 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Improvement in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS) [ Time Frame: 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
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03511534


Contacts
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Contact: Andrea Varias, MSHS 650-723-4095 ocdresearch@stanford.edu
Contact: Maria Filippou-Frye, MD, MBS 650-723-4095 mariafilippoufrye@stanford.edu

Locations
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United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Andrea Varias, MSHS    650-723-4095    ocdresearch@stanford.edu   
Contact: Maria Filippou-Frye, MD, MBS    650-723-4095    ocdresearch@stanford.edu   
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Carolyn Rodriguez, MD, PhD Assistant Professor, Stanford University
More Information
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Responsible Party: Carolyn Rodriguez, Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03511534    
Other Study ID Numbers: 41165
First Posted: April 30, 2018    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020

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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, Stanford University:
treatment, psychotherapy, pharmacotherapy
Additional relevant MeSH terms:
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Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders