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| Sponsor: | New York State Psychiatric Institute |
|---|---|
| Information provided by: | New York State Psychiatric Institute |
| ClinicalTrials.gov Identifier: | NCT00296725 |
Purpose
Depressed patients will have hearing tests and then be treated with up to three treatments (i.e., Fluoxetine, Imipramine and Placebo) until remitted, to see whether test results predict specific outcomes.
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depression Dysthymia Depressive Disorder NOS |
Drug: Fluoxetine Drug: Imipramine |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment, Efficacy Study |
| Official Title: | Dichotic Listening as a Predictor of Placebo and Medication Response in Depression |
| Estimated Enrollment: | 130 |
| Study Start Date: | April 1994 |
Preliminary data suggest that depressed patients with increased left hemispheric laterality of perceptual processing are unlikely to improve during six weeks' treatment with placebo, while being very responsive to either imipramine or fluoxetine. Depressed patients who do not show evidence of poor right hemispheric functioning respond significantly more often to placebo than those with poor right hemispheric functioning, and do not show an advantage of drug over placebo. 100 depressed patients will be tested with verbal and nonverbal dichotic tests, and then treated sequentially with Placebo, Fluoxetine and Imipramine until remitted. Preferential hemisphere for auditory processing will be correlated with treatment outcome.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New York | |
| Depression Evaluation Service, New York State Psychiatric Institute | |
| New York, New York, United States, 10032 | |
| Principal Investigator: | Jonathan W. Stewart, MD. | New York State Psychiatric Institute - Columbia University Department of Psychiatry |
More Information
| Responsible Party: | New York State Psychiatric Institute ( Jonathon W. Stewart, M.D. ) |
| Study ID Numbers: | IRB4217R, continuation of IRB3112;, became IRB5294R. |
| Study First Received: | February 24, 2006 |
| Last Updated: | January 14, 2008 |
| ClinicalTrials.gov Identifier: | NCT00296725 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Major Depression Dysthymia Depression NOS Dichotic Listening |
Fluoxetine Imipramine Placebo Predictors |
|
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Depression Adrenergic Agents Molecular Mechanisms of Pharmacological Action Adrenergic Uptake Inhibitors Physiological Effects of Drugs Psychotropic Drugs Depressive Disorder, Major Depressive Disorder Serotonin Uptake Inhibitors Pharmacologic Actions |
Antidepressive Agents, Tricyclic Behavioral Symptoms Fluoxetine Imipramine Serotonin Agents Mental Disorders Therapeutic Uses Mood Disorders Dysthymic Disorder Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |