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NCT Number: NCT05359562

How Hormones and Exposure and Response Prevention (EX/RP) Affect the Brain of People With OCD

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.

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Key information

Conditions

OCD

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York State Psychiatric Institute, New York, United States

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About this study

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 ratings before and after a brief course of EX/RP. Female participants will be randomized to complete brief EX/RP during distinct phases of their menstrual cycles. This design will allow the investigators to study the effects of hormonal variation during the menstrual cycle and sex on the fear extinction network and on EX/RP outcome. The long-term goal is to optimize EX/RP for individuals suffering from OCD. Men will also be recruited for this study to further explore biological sex differences. The results will elucidate treatment mechanisms and could lead to personalized treatment recommendations for women with OCD.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Exposure & Response Prevention (EX/RP)

Behavioral

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 outcomes

  1. fMRI

    Time frame: Baseline to approximately 4 weeks later

    Slope of change in brain activation (fMRI)

  2. OCD Symptoms

    Time frame: Baseline to approximately 4 weeks later

    Slope of change in Obsessive Compulsive Symptom Severity (Yale-Brown Obsessive Compulsive Scale)

Secondary outcomes

  1. rs fMRI

    Time frame: Baseline to approximately 4 weeks later

    Slope of change in resting state functional connectivity (fMRI)

Study contacts

Contact information is provided by the study sponsor or research team.

Bryanna Mackey

CONTACT

[email protected]

2157463344

Sara Rose Shannon, BS, MS

CONTACT

[email protected]

6467748082

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Columbia University
  • National Institute of Mental Health (NIMH)
  • New York State Psychiatric Institute
  • New York University

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
May 4, 2022
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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