Brain Network Changes Accompanying and Predicting Responses to Pharmacotherapy in OCD
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.
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…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Inclusion criteria for all groups will include: (i) Adults, Men and women will be included, in a 1:1 ratio; and efforts will be made to recruit racial and ethnic subgroups. Groups will be further matched on age, handedness; and later, in analysis, on educational status and smoking history. (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. * Additional inclusion criteria: * OCD Participants: (i) a DSM diagnosis of O…
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.
Location
- Yale OCD Research Clinic - CMHC/CNRU, 34 Park STNew Haven, Connecticut