Clinical trial NCT05359562: How Hormones and Exposure and Response Prevention (EX/RP) Affect the Brain of People With OCD
Official title: Harnessing Hormonal Variation to Probe Neural Mechanisms and Optimize CBT Outcomes for OCD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: OCD
Keywords: OCD
Exposure and Ritual Prevention
Extinction Learning
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: New York State Psychiatric Institute
name: New York University
name: Research Foundation for Mental Hygiene, Inc. / Columbia University
name: National Institute of Mental Health (NIMH)
First posted: 2022-05-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

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

Primary outcomes:
measure: fMRI
timeFrame: Baseline to approximately 4 weeks later
measure: OCD Symptoms
timeFrame: Baseline to approximately 4 weeks later
Secondary outcomes:
measure: rs fMRI
timeFrame: Baseline to approximately 4 weeks later
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Edna B Foa, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: New York State Psychiatric Institute
name: Helen B Simpson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: