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

OCD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05359562
• Other study ID #: 1R01MH121608-01A1
• Secondary ID: 1R01MH121597-01A
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2022
• Est. completion date: June 2026

Study information

• Verified date: August 2023
• Source: University of Pennsylvania
• Contact: Bryanna Mackey
• Phone: 2157463344
• Email: Bryanna.Mackey[@]Pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• OCD

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (5)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute of Mental Health (NIMH), New York State Psychiatric Institute, New York University, Research Foundation for Mental Hygiene, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fMRI	Slope of change in brain activation (fMRI)	Baseline to approximately 4 weeks later
Primary	OCD Symptoms	Slope of change in Obsessive Compulsive Symptom Severity (Yale-Brown Obsessive Compulsive Scale)	Baseline to approximately 4 weeks later
Secondary	rs fMRI	Slope of change in resting state functional connectivity (fMRI)	Baseline to approximately 4 weeks later