Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Lack of funding to complete the trial phase of the study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo and Citalopram | Experimental | 4 weeks of 1 placebo pill/day and 12 weeks of citalopram 20-40 mg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug |
| ||
| Citalopram |
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Neuropsychological functioning of patients with depression | 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. |
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry | Ann Arbor | Michigan | 48108 | United States |
Not provided
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D015283 | Citalopram |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Fast acting antidepressant-like treatment. administered i.v. during the fMRI scanning session | Drug | Fast acting antidepressant-like treatment administered intravenously for 35 min. during the fMRI scanning session. |
|
| At baseline |
| BDNF Val66Met single nucleotide polymorphism(SNP)genotyping | 5ml of blood drawn per participants will be used for genotyping | At baseline |
| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |