Actively Recruiting
Brain Network Changes Accompanying and Predicting Responses to Pharmacotherapy in OCD
Led by Yale University · Updated on 2025-08-14
100
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating brain network changes in adults with obsessive-compulsive disorder (OCD) to find predictors and connections related to responses to fluoxetine, a common medication for OCD. The study includes healthy adults as a comparison group and uses advanced brain imaging techniques to better understand OCD symptoms and treatment effects. The research aims to identify brain markers linked with OCD symptoms and how patients respond to fluoxetine treatment. The study involves two main groups: healthy adults who will have one brain scan at the start without treatment, and adults with OCD who are not currently on medication. Those with OCD will be randomly assigned in a double-blind manner to either start fluoxetine immediately or after a 6-week placebo period. Brain scans will be done at the beginning and during treatment to observe changes. Analyses will explore brain connectivity related to OCD symptoms and treatment response. Participants will undergo clinical assessments and functional MRI scans to monitor brain activity. Those with OCD will be evaluated over 18 weeks, including checking symptom severity and other related measures such as depression and anxiety. The study will track changes in OCD symptoms as the primary outcome, with several secondary measures also assessed. Participants will be closely monitored to ensure safety and study adherence throughout the trial.
CONDITIONS
Brief Title
Brain Network Changes Accompanying and Predicting Responses to Pharmacotherapy in OCD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years, including men and women in a 1:1 ratio
- Willing and able to participate in all study procedures, including clinical assessments and fMRI scans
- Signed informed consent approved by Yale Human Investigations Committee
- OCD participants must have a DSM diagnosis of OCD with a baseline Y-BOCS score of 16 or higher
- OCD participants must be treatment-seeking and clinically appropriate for fluoxetine pharmacotherapy
- Women of childbearing potential must not be pregnant or intending to become pregnant and must use reliable birth control during the study
- Healthy control participants must have no current DSM diagnosis and no family history of OCD or related disorders in first- or second-degree relatives
You will not qualify if you...
- Any unstable medical, psychiatric, or neurological condition requiring urgent treatment
- Substance use disorder within the past 6 months
- Use of psychotropic medications within the past 8 weeks, except occasional sleep aid or analgesic
- Use of sleep aid or prescription analgesic within 3 days of scan
- History of primary psychotic disorder or mania
- Positive substance use on urine toxicology
- Major neurological disease or history of major head trauma
- Pregnancy
- Presence of metal in the body or other MRI contraindications
- Severe claustrophobia, back pain, or other conditions making MRI difficult
- OCD participants with past allergy or adverse reaction to fluoxetine or other SSRIs
- OCD participants with documented nonresponse to adequate fluoxetine treatment
- Patients taking Coumadin or Monoamine oxidase inhibitors (MAOIs)
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 18 weeks
Participants with OCD are randomized to receive either immediate fluoxetine pharmacotherapy or delayed fluoxetine treatment following a 6-week placebo lead-in. Healthy control participants undergo baseline imaging without treatment.
fMRI scans at baseline and periodically during treatment; medication taken daily
Trial Site Locations
Total: 1 location
1
Yale OCD Research Clinic - CMHC/CNRU, 34 Park ST
New Haven, Connecticut, United States, 06519
Actively Recruiting
Research Team
Y
Yale OCD Research Clinic
S
Stephen Kichuk, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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