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Brain Network Changes Accompanying and Predicting Responses to Pharmacotherapy in OCD | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

Brain Network Changes Accompanying and Predicting Responses to Pharmacotherapy in OCD

NCT04131829•Yale University

Summary

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.

Detailed Description

The proposed study intends to recruit 2 groups: 1. Matched healthy control participants will be imaged with one fMRI at baseline as a no-treatment comparison group; and 2. a randomized, double-blind group of unmedicated OCD participants who will be assigned to begin either immediate or placebo-delayed treatment, and who will be imaged with fMRIs at baseline and over the course of treatment with a selective serotonin reuptake inhibitor (SSRI), fluoxetine. Hypothesis-driven analyses and exploratory analyses will be performed in parallel. This study will address the following Specific Aims: 1. Identification of neural dysconnectivity associated with OCD symptomatology. 2. Characterizing neural markers of clinical response to SSRI pharmacotherapy. 3. Mapping neural predictors of clinical response to pharmacotherapy.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•(ii) signed informed consent, approved by the Yale Human Investigations Committee; and (iii) ability and willingness to participate in all study procedures, including clinical assessments and fMRI scans.
•OCD Participants:
•(i) a DSM diagnosis of OCD, established as detailed above; (ii) a baseline Y-BOCS of ≥16; (iii) no current psychoactive medication, with the exception of the occasional use of a PRN medication for sleep; (iv) treatment seeking, and clinically appropriate for fluoxetine pharmacotherapy; (v) for women of childbearing potential, not pregnant or intending to become pregnant, and willing to use reliable birth control over the course of the study, either prescribed contraceptive (oral contraceptive, injectable, or implant) or one barrier method (e.g. diaphragm with spermicide, intrauterine device, cervical cap). Women of childbearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy tests at the study baseline and on each scan day appointment prior to the MRI scan.
•Healthy Control Participants:
•(i) no current DSM diagnosis (by clinician interview confirmed by SCID or MINI); (ii) no documented or clinically suspected family history in a first- or second- degree relative of OCD, Tourette syndrome, hoarding disorder, body dysmorphic disorder, or a compulsive grooming disorder.

Exclusion Criteria

•(i) any unstable medical, psychiatric, or neurological condition (including active or otherwise problematic suicidality) that may necessitate urgent treatment; (ii) any substance use disorder within the past 6 months; (iii) use of psychotropic medications within the past 8 weeks, with the exception of occasional use of a sleep aid or analgesic; (iv) use of an as-needed sleep aid or prescription analgesic within 3 days of the scan; (v) any history of a primary psychotic disorder or of mania; (vi) any evidence of substance use on urine toxicology testing; (vii) any major neurological disease or history of major head trauma, including concussion with extended loss of consciousness; (viii) pregnancy; (ix) any metal in the body or other contraindication to MRI scanning; (x) severe claustrophobia, back pain, or other condition that may make an extended MR scan difficult or lead to excessive movement during the scan.
•OCD Participants:
•(i) past allergy or adverse reaction to fluoxetine or another SSRI, or other clinical contraindication to fluoxetine pharmacotherapy; (ii) documented nonresponse to a past trial of fluoxetine of appropriate dose (≥40 mg/dy) and duration (≥12 weeks).
•(iii) Patients taking Coumadin or Monoamine oxidase inhibitors (MAOIs) will be excluded from the study.

Locations (1)

Yale OCD Research Clinic - CMHC/CNRU, 34 Park ST

New Haven, Connecticut, United States

Key Dates

Start Date

October 14, 2019

Primary Completion Date

June 30, 2026

Completion Date

December 31, 2026

Last Updated

August 14, 2025

Enrollment

100

ESTIMATED participants

Conditions

Obsessive-Compulsive Disorder

Interventions

Fluoxetine - immediate treatment

DRUG

Fluoxetine - delayed treatment

DRUG

Contacts

Yale OCD Research Clinic

CONTACT

1-855-623-9253 ocd.research@yale.edu

Stephen Kichuk, MPH

CONTACT

203-974-7534 stephen.kichuk@yale.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Brain Network Changes Accompanying and Predicting Responses to Pharmacotherapy in OCD

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