Escitalopram in Adult Patients With Major Depressive Disorder

Forest Laboratories877 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

877

Conditions

Major Depressive Disorder

Interventions

EscitalopramDRUG

Escitalopram low dose, oral administration, once daily dosing for 8 weeks.

PlaceboDRUG

Placebo, oral administration, once daily dosing for 8 weeks

EscitalopramDRUG

Escitalopram high dose, oral administration, once daily dosing for 8 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (45)

Outcomes

Primary Outcomes

Change From Baseline in Total Montgomery Asberg Depression Rating Scale (MADRS) at 8 Weeks.

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).

Time frame: Change from baseline in MADRS total score at week 8

Secondary Outcomes

Change From Baseline in Hamiltion Rating Scale for Depression (HAM-D) at Week 8

The HAMD is a clinician-rated 24-item scale was used to rate the patient's depressive state. It was also used to identify obsessive-compulsive, genital, and somatic symptoms, as well as diurnal variation in the presence of symptoms. Each item was scored on a 3, 4 or 5-point Likert scale. A score of 0 indicated the absence of symptoms, and a score of 2, 3 or 4 indicated symptoms of maximum severity. The total score range is 0 to 74 (higher score indicates a greater depressive state).

Time frame: Change from baseline in HAM-D at week 8

Data from ClinicalTrials.gov

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Forest Investigative Site

Phoenix, Arizona, United States

Forest Investigative Site

Arcadia, California, United States

Forest Investigative Site

Encino, California, United States

Forest Investigative Site

Garden Grove, California, United States

Forest Investigative Site

Irvine, California, United States

Forest Investigative Site

Los Alamitos, California, United States

Forest Investigative Site

Denver, Colorado, United States

Forest Investigative Site

Washington D.C., District of Columbia, United States

Forest Investigative Site

Bradenton, Florida, United States

Forest Investigative Site

Jacksonville, Florida, United States

...and 35 more locations