Escitalopram Combination Comparison Study for Adult Patients With Major Depressive Disorder
This trial is active, not recruiting.
|Condition||major depressive disorder|
|Sponsor||Pharmacology Research Institute|
|Start date||March 2005|
|Trial identifier||NCT00239954, PRI#591 & #592|
The purpose of this study is to evaluate the effectiveness, safety and tolerability of an escitalopram combination treatment compared to single treatments, and to placebo in patients with major depressive disorder.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Los Alamitos, CA||Pharmacology Research Institute||no longer recruiting|
|Newport Beach, CA||Pharmacology Research Institute||no longer recruiting|
|Northridge, CA||Pharmacology Research Institute||no longer recruiting|
|Riverside, CA||Pharmacology Research Institute||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Montgomery Asberg Depression Rating Scale (MADRS)
Hamilton Depression Rating Scale (HAMD)
Male or female participants from 18 years up to 80 years old.
Inclusion Criteria: - Patients must meet Diagnostic and Statistical Manual, Fourth Edition (DSM-IV) diagnostic criteria for Major Depressive Disorder - The patient's current depressive episode must be at least 12 weeks in duration. Exclusion Criteria: - Women who are pregnant, women who will be breastfeeding during the study, and women of childbearing potential who are not practicing a reliable method of birth control. - Patients who currently meet DSM-IV criteria for : a. bipolar disorder; b. schizophrenia or any psychotic disorder; c. obsessive-compulsive disorder; d. mental retardation or any pervasive developmental disorder or cognitive disorder. - Patients who are considered a suicide risk. - Patients with a history of seizure disorder, or any history of seizure, stroke, significant head injury, or any other condition that predisposes toward risk of seizure.
|Official title||Fixed Dose Comparison of Escitalopram Combination in Adult Patients With Major Depressive Disorder|
|Principal investigator||Jon F. Heiser, MD|
|Description||Both active drugs being tested, alone and in combination, in this study are currently available antidepressants. However, the doses used in this study are lower than the standard approved doses.|
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