How Hormones and Exposure and Response Prevention (EX/RP) Affect the Brain of People With OCD
ConditionOCD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorUniversity of Pennsylvania
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Exposure & Response Prevention (EX/RP)
Treatment groups
120 Participants
are divided into 3 treatment groupsSponsors and collaborators
University of Pennsylvania
Lead sponsor
New York State Psychiatric Institute
Collaborator
New York University
Collaborator
Columbia University
Collaborator
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov