Effects of Hormones on OCD Treatment with Exposure and Response Prevention
Official title: Harnessing Hormonal Variation to Probe Neural Mechanisms and Optimize CBT Outcomes for OCD
Run by University of Pennsylvania · NCT05359562 · Data updated 2026-11-12
This study is testing how hormonal changes during the menstrual cycle affect the success of a therapy for obsessive-compulsive disorder (OCD) in both men and women.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 2 sites (New York, New York and 1 other locations) |
| Status | Recruiting |
| Started | June 15, 2022 |
| Main results expected | June 30, 2028 |
| Study ends | June 30, 2028 |
| Registry record updated | July 22, 2026 |
| Trial ID | NCT05359562 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are men and women aged 18-45 with a DSM-5 diagnosis of OCD who are not on psychotropic medications and are able to tolerate a treatment-free period.
✕Probably not a fit
Patients who are pregnant, using hormonal birth control, or have significant comorbid psychiatric conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates how hormonal fluctuations during the menstrual cycle influence the brain's fear extinction network and the effectiveness of exposure and response prevention (EX/RP) therapy for obsessive-compulsive disorder (OCD). Participants, both male and female, will undergo neuroimaging and hormonal assessments before and after a brief EX/RP protocol. Female participants will be randomized to receive treatment during different menstrual phases to assess the impact of hormones on treatment outcomes. The goal is to enhance EX/RP therapy for individuals with OCD by understanding the role of hormonal variation and sex differences in treatment response.
Why it matters
Potential benefit: If successful, this study could lead to personalized treatment strategies for women with OCD, improving their therapeutic outcomes.
How similar studies have gone: Other studies have explored hormonal influences on mental health treatments, but this specific approach examining menstrual cycle phases in OCD therapy is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Diagnosis of OCD; 2. Male and female subjects aged between 18- 45; 3. Women must be menstruating and regularly cycling 4. Ability to tolerate a treatment-free period; 5. No psychotropic medication in the past 12 weeks 6. At entry, at least moderate severity OCD 7. Willingness and ability to give written informed consent after full explanation of study procedures. Exclusion Criteria: 1. Use of birth control (oral contraception or IUD) that affects the menstrual cycle, or menopause. 2. Pregnancy. Women of childbearing potential will be required to sign a statement indicating their intention to avoid pregnancy during the study. 3. Neurologic or medical condition that would prevent safe participation in the full study protocol. 4. Any contradiction to magnetic resonance imaging (e.g., metallic implants or devices). 5. Comorbid psychiatric conditions that significantly elevate the risks associated with study participation or confound results. 6. Patients with prominent suicidal ideation or with a recent suicide attempt. 7. Current psychotherapy
Where it's running
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New York State Psychiatric Institute
New York, New York, United States Recruiting -
University of Pennsylvania
Philadelphia, Pennsylvania, United States Recruiting
Study contacts
- Principal investigator: Lily Brown, PhD — University of Pennsylvania
- Study coordinator: Bryanna Mackey
- Email: Bryanna.Mackey@Pennmedicine.upenn.edu
- Phone: 2157463344
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.