Effects of Hormones on OCD Treatment with Exposure and Response Prevention

Harnessing Hormonal Variation to Probe Neural Mechanisms and Optimize CBT Outcomes for OCD

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

• Phase: NA
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: University of Pennsylvania (other)
• Locations: 2 sites (New York, New York and 1 other locations)
• Trial ID: NCT05359562 on ClinicalTrials.gov

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.

Who should consider this trial

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.

Not a fit: Patients who are pregnant, using hormonal birth control, or have significant comorbid psychiatric conditions may not benefit from this study.

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 performed: Other studies have explored hormonal influences on mental health treatments, but this specific approach examining menstrual cycle phases in OCD therapy is relatively novel.

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

Where this trial is running

New York, New York and 1 other locations

• New York State Psychiatric Institute — New York, New York, United States (RECRUITING)
• University of Pennsylvania — Philadelphia, Pennsylvania, United States (RECRUITING)

Study contacts

• Principal investigator: Edna B Foa, PhD — University of Pennsylvania
• Study coordinator: Bryanna Mackey

Conditions: OCD, Exposure and Ritual Prevention, Extinction Learning