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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

Tracking Information
First Submitted Date  ICMJE April 18, 2018
First Posted Date  ICMJE April 30, 2018
Last Update Posted Date May 14, 2020
Actual Study Start Date  ICMJE June 23, 2017
Estimated Primary Completion Date June 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2018)		 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 18, 2018)		 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 the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open/Aftercare Treatment for Participants Diagnosed With Obsessive Compulsive Disorder
Official Title  ICMJE Open/Aftercare Treatment for Participants Diagnosed With Obsessive Compulsive Disorder
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE OCD
Intervention  ICMJE
  • Behavioral: Psychotherapy
    Evidenced based psychotherapy by a trained psychologist
  • Other: Pharmacotherapy
    Pharmacotherapy by a psychiatrist
Study Arms  ICMJE
  • Active Comparator: Psychotherapy
    Participants will receive evidenced based psychotherapy by a trained psychologist
    Intervention: Behavioral: Psychotherapy
  • Active Comparator: Pharmacotherapy
    Participants will receive pharmacotherapy by a psychiatrist
    Intervention: Other: Pharmacotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 18, 2018)		 200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2026
Estimated Primary Completion Date June 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Andrea Varias, MSHS 650-723-4095 ocdresearch@stanford.edu
Contact: Maria Filippou-Frye, MD, MBS 650-723-4095 mariafilippoufrye@stanford.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03511534
Other Study ID Numbers  ICMJE 41165
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Carolyn Rodriguez, Stanford University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Stanford University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Carolyn Rodriguez, MD, PhD Assistant Professor, Stanford University
PRS Account Stanford University
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP