Status:
RECRUITING
How Hormones and Exposure and Response Prevention (EX/RP) Affect the Brain of People With OCD
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
New York State Psychiatric Institute
New York University
Conditions:
OCD
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
Studies show that hormones affect the brain's fear extinction network, which is relevant for therapy involving exposure and response prevention (EX/RP), a first-line treatment for obsessive compulsive...
Detailed Description
This study involves neuroimaging and a brief EX/RP protocol. The investigators will recruit both male and female participants. All participants will complete neuroimaging, hormonal assays and symptom ...
Eligibility Criteria
Inclusion
- Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Diagnosis of OCD;
- Male and female subjects aged between 18- 45;
- Women must be menstruating and regularly cycling
- Ability to tolerate a treatment-free period;
- No psychotropic medication in the past 12 weeks
- At entry, at least moderate severity OCD
- Willingness and ability to give written informed consent after full explanation of study procedures.
Exclusion
- Use of birth control (oral contraception or IUD) that affects the menstrual cycle, or menopause.
- Pregnancy. Women of childbearing potential will be required to sign a statement indicating their intention to avoid pregnancy during the study.
- Neurologic or medical condition that would prevent safe participation in the full study protocol.
- Any contradiction to magnetic resonance imaging (e.g., metallic implants or devices).
- Comorbid psychiatric conditions that significantly elevate the risks associated with study participation or confound results.
- Patients with prominent suicidal ideation or with a recent suicide attempt.
- Current psychotherapy
Key Trial Info
Start Date :
June 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05359562
Start Date
June 15 2022
End Date
June 1 2026
Last Update
October 7 2025
Active Locations (2)
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1
New York State Psychiatric Institute
New York, New York, United States, 10032
2
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104