Major Depressive Disorder
Conditions
Keywords
Major Depressive Disorder
Brief summary
The purpose of this study is to evaluate the safety and efficacy of escitalopram to an active comparator in severely depressed patients
Detailed description
Escitalopram is the S-enantiomer of citalopram. Both escitalopram and citalopram are selective serotonin reuptake inhibitors (SSRIs) and are used to treat depression in adults. This study is designed to evaluate the safety and efficacy of escitalopram and an active comparator in severely depressed patients.
Interventions
DRUGescitalopram
Sponsors
Forest Laboratories
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients must meet DSM-IV criteria for Major Depressive Disorder. * Patients must have severe depression. * MADRS greater than or equal to 30
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 are considered a suicide risk. * Patients who currently meet DSM-IV criteria for: a principal diagnosis for Axis I disorder other than MDD (comorbid GAD is allowed), bipolar disorder, schizophrenia or any psychotic disorder, obsessive-compulsive disorder, dysthymia. * Patients with a family history of bipolar disorder, schizophrenia, or any psychotic disorder. * Patients with history of any psychotic disorder or any psychotic feature.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to premature discontinuation | — |
Secondary
| Measure | Time frame |
|---|---|
| Montgomery Asberg Depression Rating Scale (MADRS) | — |
Countries
United States
Outcome results
None listed