NCT05359562 How Hormones and Exposure and Response Prevention (EX/RP) Affect the Brain of People With OCD
| NCT ID | NCT05359562 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pennsylvania |
| Condition | OCD |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2022-06-15 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2022-06-15 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 disorder (OCD). This study will examine the effect of delivering EX/RP to women during different phases in their menstrual cycle to determine the effects of hormones on the fear extinction network and on their OCD symptoms.
Eligibility 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
Contact & Investigator
Lily Brown, PhD
PRINCIPAL INVESTIGATOR
University of Pennsylvania
Frequently Asked Questions
Who can join the NCT05359562 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying OCD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05359562 currently recruiting?
Yes, NCT05359562 is actively recruiting participants. Contact the research team at Bryanna.Mackey@Pennmedicine.upenn.edu for enrollment information.
Where is the NCT05359562 trial being conducted?
This trial is being conducted at New York, United States, Philadelphia, United States.
Who is sponsoring the NCT05359562 clinical trial?
NCT05359562 is sponsored by University of Pennsylvania. The principal investigator is Lily Brown, PhD at University of Pennsylvania. The trial plans to enroll 120 participants.