A Double-blind, Fixed-dose Study of Escitalopram in Adult Patients With Major Depressive Disorder
Overview
- Phase
- Phase 3
- Intervention
- Escitalopram
- Conditions
- Major Depressive Disorder
- Sponsor
- Forest Laboratories
- Enrollment
- 877
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Total Montgomery Asberg Depression Rating Scale (MADRS) at 8 Weeks.
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
This is a short-term study to evaluate the efficacy, safety, and tolerability of escitalopram in adult patients (18 to 65 years of age) with moderate to severe depression. Patients completing the study may be eligible to enter a long-term open-label extension study with escitalopram.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients must meet Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR) diagnostic criteria for Major Depressive Disorder.
- •The patient's current depressive episode must be at least 8 weeks in duration.
Exclusion Criteria
- •Women who are pregnant, women who will be breastfeeding during the study, and women with childbearing potential who are not practicing a reliable method of birth control.
- •Patients with a history of meeting DSM-IV-TR criteria for: a. any manic or hypomanic episode; b. schizophrenia or any other psychotic disorder; c. obsessive-compulsive disorder.
- •Patients who are considered a suicide risk
- •Patients with a history of seizures (including seizure disorder), stroke, significant head injury, central nervous system tumors, or any other condition that predisposes patients to a risk for seizure.
Arms & Interventions
2
Escitalopram low dose
Intervention: Escitalopram
3
Escitalopram high dose
Intervention: Escitalopram
1
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Change From Baseline in Total Montgomery Asberg Depression Rating Scale (MADRS) at 8 Weeks.
Time Frame: Change from baseline in MADRS total score at week 8
The MADRS is a 10-item clinician-rated scale that was used to assess depressive symptomatology over the patient's prior week. Patients were rated on 10 items designed to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item was scored on a 7-point Likert scale; a score of 0 indicated the absence of symptoms, and a score of 6 indicated symptoms of maximum severity. The total score range is 0 to 60 (higher score indicates a greater severity of symptoms).
Secondary Outcomes
- Change From Baseline in Hamiltion Rating Scale for Depression (HAM-D) at Week 8(Change from baseline in HAM-D at week 8)