Neuroimaging Predictors of Antidepressant Treatment Outcome
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).
Drug: Fast acting antidepressant-like treatment. administered i.v. during the fMRI scanning session
|Study Design:||Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
- 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 ] [ Designated as safety issue: No ]
- Depression severity assessed with several depressive questionnaires. [ Time Frame: Every two weeks until the end of the trial (16 weeks total), or until the participants leave the study. ] [ Designated as safety issue: No ]
- Neuropsychological functioning of patients with depression [ Time Frame: At baseline ] [ Designated as safety issue: No ]
Affect processing: Emotional Words Task and Facial Emotion Perception test. Attention and Inhibitory Control: Parametric Go/NoGo, Trail Making test and the Stroop Color Word test .
Inferential Reasoning (including cost-benefit analysis): Delayed Discounting of Money Rewards, Iowa Gambling Task, Common Difference effect gambling task and the WCST.
- BDNF Val66Met single nucleotide polymorphism(SNP)genotyping [ Time Frame: At baseline ] [ Designated as safety issue: No ]5ml of blood drawn per participants will be used for genotyping
|Study Start Date:||July 2013|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Experimental: Placebo and Citalopram
4 weeks of 1 placebo pill/day and 12 weeks of citalopram 20-40 mg/day
Other Name: CelexaDrug: Fast acting antidepressant-like treatment. administered i.v. during the fMRI scanning session
Fast acting antidepressant-like treatment administered intravenously for 35 min. during the fMRI scanning session.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02000726
|Contact: Erich Averyfirstname.lastname@example.org|
|United States, Michigan|
|Department of Psychiatry||Recruiting|
|Ann Arbor, Michigan, United States, 48108|
|Contact: Erich Avery 734-615-7218 email@example.com|
|Principal Investigator: Marta Pecina Iturbe, MD PhD|