Neuroimaging Predictors of Antidepressant Treatment Outcome
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- University of Michigan
- Locations
- 1
- Primary Endpoint
- Blood-oxygen-level dependent (BOLD) responses during the Real-Time Neurofeedback Task.
Study Overview
Brief Summary
Current medical therapies for depression take weeks to achieve full efficacy, and are ineffective in many patients or cause intolerable side effects, emphasizing the need for a deeper understanding of depression and its treatment. Identifying early brain biomarkers of treatments responses seems necessary to improve antidepressant treatment outcome. In this study we aim to detect early brain responses to a fast acting antidepressant-like treatment administered intravenously during a Real-Time Neurofeedback functional magnetic resonance imaging (MRI) Task to predict antidepressant treatment outcome in depression. At completion of the neuroimaging task, participants will enter a placebo-controlled clinical trial with a selective serotonin reuptake inhibitor (SSRI).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Inclusion criteria will include Hamilton Depressive Rating Scale (HDRS) scores >15 and Snaith-Hamilton Pleasure Scale scores (SHAPS) > 7.
Exclusion Criteria
- •suicidal ideation, comorbid conditions that are medical, neurological or psychiatric, pregnancy, use of hormones (including birth control) or use of psychotropic agents. We will only permit certain past anxiety disorder diagnoses, including generalized anxiety, panic, agoraphobia, social phobia.
- •We will also exclude left-handed individuals and patients who have used any centrally acting medications, nicotine, or recreational drugs within the past 2 months.
Arms & Interventions
Placebo and Citalopram
4 weeks of 1 placebo pill/day and 12 weeks of citalopram 20-40 mg/day
Intervention: Placebo (Drug)
Placebo and Citalopram
4 weeks of 1 placebo pill/day and 12 weeks of citalopram 20-40 mg/day
Intervention: Citalopram (Drug)
Placebo and Citalopram
4 weeks of 1 placebo pill/day and 12 weeks of citalopram 20-40 mg/day
Intervention: Fast acting antidepressant-like treatment. administered i.v. during the fMRI scanning session (Drug)
Outcomes
Primary Outcomes
Blood-oxygen-level dependent (BOLD) responses during the Real-Time Neurofeedback Task.
Time Frame: BOLD responses will be assessed at baseline and depression severity will be assessed at baseline
Secondary Outcomes
- Depression severity assessed with several depressive questionnaires.(Every two weeks until the end of the trial (16 weeks total), or until the participants leave the study.)
Investigators
Marta Pecina Iturbe
MD PhD
University of Michigan