Recruiting

Hormones & EX/RP

Sponsor:

University of Pennsylvania

Code:

NCT05359562

Conditions

OCD

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Exposure & Response Prevention (EX/RP)

Study Details

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.

Conditions

OCD

Study ID

NCT05359562

Start date

Jun 15, 2022

Status verified date

Jul, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Active Comparator

Male participants will receive a brief EX/RP protocol within a 10-day window.

experimental: Experimental 1

Half of female participants will be randomized to receive a brief EX/RP protocol within the first 10 days after the start of menstruation (early follicular phase).

experimental: Experimental 2

Half of female participants will be randomized to receive a brief EX/RP protocol in days 12-22 of the menstrual cycle (late follicular, early luteal phase).

Interventions

Exposure & Response Prevention (EX/RP)

Exposure and Response Prevention (EX/RP) is a type of Cognitive Behavioral Treatment for treating OCD. This is a brief protocol consisting of 8 sessions of exposure and Response Prevention (EX/RP). This protocol includes two psychoeducation/planning sessions, followed by six exposure sessions.

Primary outcome measure

  • fMRI [ Time Frame: Baseline to approximately 4 weeks later ]
  • OCD Symptoms [ Time Frame: Baseline to approximately 4 weeks later ]

Central Contacts and Locations

Locations

New York State Psychiatric Institute

Recruiting

New York, New York, United States, 10032

Contacts

Principal Investigator:

Helen B Simpson, MD, PhD

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Principal Investigator:

Lily Brown, PhD

More Information

Sponsor

University of Pennsylvania

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Keywords

  • OCD
  • Exposure and Ritual Prevention
  • Extinction Learning

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-07-22.