Brain Network Changes Accompanying and Predicting Responses to Pharmacotherapy in OCD
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Obsessive Compulsive Disorder
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: 80 OCD patients and 40 healthy participants matched on demographics will be recruited and asked to complete Structural (sMRI) and Functional (fMRI) Magnetic Resonance Imaging. Patients with OCD will be randomized to immediate monotherapy or 6-week placebo-delayed monotherapy, with fluoxetine.Masking: Double (Investigator, Outcomes Assessor)Primary Purpose: Basic Science
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
Description
The proposed study intends to recruit 2 groups: Matched healthy control participants will be imaged with one fMRI at baseline as a no-treatment comparison group; and a randomized, double-blind group of unmedicated OCD participants who will be assigned to begin either immediate or placebo-delayed tre...
The proposed study intends to recruit 2 groups: Matched healthy control participants will be imaged with one fMRI at baseline as a no-treatment comparison group; and 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: Identification of neural dysconnectivity associated with OCD symptomatology. Characterizing neural markers of clinical response to SSRI pharmacotherapy. Mapping neural predictors of clinical response to pharmacotherapy.
Tracking Information
- NCT #
- NCT04131829
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Principal Investigator: Christopher Pittenger, MD, PhD Associate Professor of Psychiatry; Director, Yale OCD Research Clinic