This trial is active, not recruiting.

Condition major depressive disorder
Treatment escitalopram
Phase phase 3
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

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

Montgomery Asberg Depression Rating Scale (MADRS)
time frame:

Secondary Outcomes

Hamilton Depression Rating Scale (HAMD)
time frame:

Eligibility Criteria

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2012.
Information provided to ClinicalTrials.gov by Pharmacology Research Institute.