NCT04131829

Brain Network Changes Accompanying and Predicting Responses to Pharmacotherapy in OCD

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Obsessive-Compulsive Disorder

Interventions

Type	Name	Description
DRUG	Fluoxetine - 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.
DRUG	Fluoxetine - 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.

Timeline

• Start date: 2019-10-14
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2019-10-18
• Last updated: 2025-08-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study