Brain Network Changes Accompanying and Predicting Responses to Pharmacotherapy in OCD

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT04131829
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Obsessive-Compulsive Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Fluoxetine - immediate treatment — DRUG
    Following the Baseline assessment, OCD subjects will be randomized to receive either immediate fluoxetine monotherapy or delayed fluoxetine, after a 6-week placebo lead-in.
  • Fluoxetine - delayed treatment — DRUG
    Following the Baseline assessment, OCD subjects will be randomized to receive either immediate fluoxetine monotherapy or delayed fluoxetine, after a 6-week placebo lead-in.

Study Details

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.

Key Dates

Start date
Oct 14, 2019
Status verified
Aug 2025
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • No Intervention: Healthy Controls
    The healthy control group will be an age matched sample of unmedicated healthy adults who will be recruited and imaged once at baseline and the data compared with that of OCD subjects at baseline.
  • Experimental: OCD Group
    The OCD group will comprise of unmedicated individuals with clinically significant OCD symptoms. OCD Subjects will be randomized, double-blind, to receive immediate or delayed (by 6 weeks as a placebo lead-in) pharmacotherapy.

Primary Outcome Measure

Obsessive-compulsive severity change [ Time Frame: 18 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale OCD Research Clinic - CMHC/CNRU, 34 Park STNew HavenConnecticut06519
Stephen Kichuk, MPH
[email protected]
203-974-7534
OCD Research
[email protected]
1-855-623-9253

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By research site
Yale OCD Research Clinic - CMHC/CNRU, 34 Park ST· New Haven, CT

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