Depression
Conditions
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).
Interventions
DRUGPlacebo
DRUGCitalopram
DRUGFast 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.
Sponsors
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood-oxygen-level dependent (BOLD) responses during the Real-Time Neurofeedback Task. | BOLD responses will be assessed at baseline and depression severity will be assessed at baseline |
Secondary
| Measure | Time frame |
|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Neuropsychological functioning of patients with depression | At baseline | 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 | At baseline | 5ml of blood drawn per participants will be used for genotyping |
Countries
United States
Outcome results
None listed