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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• 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.

Locations
United States
New York
New York State Psychiatric Institute
RECRUITING
New York
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Contact Information
Primary
Bryanna Mackey
Bryanna.Mackey@Pennmedicine.upenn.edu
2157463344
Backup
Hannah McManus
Hannah.McManus@nyspi.columbia.edu
6467748062
Time Frame
Start Date: 2022-06-15
Estimated Completion Date: 2026-06
Participants
Target number of participants: 120
Treatments
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).
Related Therapeutic Areas
Sponsors
Collaborators: New York State Psychiatric Institute, National Institute of Mental Health (NIMH), Research Foundation for Mental Hygiene, Inc. / Columbia University, New York University
Leads: University of Pennsylvania

This content was sourced from clinicaltrials.gov