Neuroimaging Predictors of Antidepressant Treatment Outcome

Study Overview
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Brief Summary
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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).

Conditions
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Depression

Intervention / Treatment
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* Drug: Placebo
* Drug: Citalopram
* Drug: Fast acting antidepressant-like treatment. administered i.v. during the fMRI scanning session


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placebo and Citalopram<br>4 weeks of 1 placebo pill/day and 12 weeks of citalopram 20-40 mg/day | Drug: Placebo<br> <br> Drug: Citalopram<br> <br> * Other names: Celexa;Drug: Fast acting antidepressant-like treatment. administered i.v. during the fMRI scanning session<br>* Fast acting antidepressant-like treatment administered intravenously for 35 min. during the fMRI scanning session.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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. |