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
376 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
The proposed randomized, double-blind research study will use functional magnetic resonance neuroimaging using state-of-the-art HCP acquisition protocols and analytic pipelines, to identify predictors and correlates of response to an accepted first-line pharmacological treatment for obsessive-compulsive disorder.
CONDITIONS
Official 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, men and women in a 1:1 ratio, with efforts to include diverse racial and ethnic groups
- Signed informed consent approved by the Yale Human Investigations Committee
- Ability and willingness to participate in all study procedures, including clinical assessments and fMRI scans
- For OCD participants: diagnosed with OCD by DSM criteria
- Baseline Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score of 16 or higher
- Not currently on psychoactive medications except occasional use of sleep medication as needed
- Seeking treatment and suitable for fluoxetine therapy
- Women of childbearing potential must not be pregnant or intending to become pregnant and must use reliable birth control during the study
- Negative pregnancy tests at screening, baseline, and before each MRI scan for women of childbearing potential
- For healthy controls: 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, including active suicidality
- 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 before the scan
- History of primary psychotic disorder or mania
- Evidence of substance use on urine toxicology
- Major neurological disease or history of major head trauma including concussion with extended loss of consciousness
- Pregnancy
- Presence of metal in the body or any contraindication to MRI scanning
- Severe claustrophobia, back pain, or other conditions that would make MRI scanning difficult
- For OCD participants: past allergy or adverse reaction to fluoxetine or SSRIs, or other contraindications to fluoxetine
- Documented nonresponse to prior fluoxetine treatment at appropriate dose and duration
- Use of Coumadin or monoamine oxidase inhibitors (MAOIs)
AI-Screening
AI-Powered Screening
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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
CONTACT
S
Stephen Kichuk, MPH
CONTACT
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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