RecruitingPhase 1Phase 2NCT04131829

Brain Network Changes Accompanying and Predicting Responses to Pharmacotherapy in OCD


Sponsor

Yale University

Enrollment

100 participants

Start Date

Oct 14, 2019

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is using brain scans (fMRI) to understand how brain networks change in people with OCD (obsessive-compulsive disorder) when they are treated with the antidepressant fluoxetine (Prozac). It also includes healthy volunteers for comparison. **You may be eligible if...** - You are an adult (any gender) - For OCD group: you have a confirmed OCD diagnosis, moderate-to-severe symptoms (Y-BOCS score of 16 or more), are not currently on psychiatric medications (except occasional sleep aids), and are seeking treatment with fluoxetine - For healthy volunteers: you have no current psychiatric diagnosis and no close family history of OCD or related conditions - You are willing and able to undergo MRI scans **You may NOT be eligible if...** - You have an unstable medical or psychiatric condition requiring urgent treatment - You have had a substance use disorder in the past 6 months - You have a history of psychosis or mania - You are pregnant - You have metal in your body or severe claustrophobia (preventing MRI) - For OCD group: you previously tried fluoxetine at an adequate dose without improvement, or are allergic to SSRIs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFluoxetine - immediate treatment

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.

DRUGFluoxetine - delayed treatment

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.


Locations(1)

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

New Haven, Connecticut, United States

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NCT04131829


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