Escitalopram in Adult Patients With Major Depressive Disorder

• Sponsor: Forest Laboratories
• Information provided by: Forest Laboratories

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Major Depressive Disorder	Drug: Escitalopram; Drug: Placebo	Phase 3

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	877 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	A Double-blind, Fixed-dose Study of Escitalopram in Adult Patients With Major Depressive Disorder
Study Start Date :	April 2008
Actual Primary Completion Date :	February 2009

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 2; Escitalopram low dose	Drug: Escitalopram; Escitalopram low dose, oral administration, once daily dosing for 8 weeks.
Experimental: 3; Escitalopram high dose	Drug: Escitalopram; Escitalopram high dose, oral administration, once daily dosing for 8 weeks
Placebo Comparator: 1; Placebo	Drug: Placebo; Placebo, oral administration, once daily dosing for 8 weeks

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Change From Baseline in Hamiltion Rating Scale for Depression (HAM-D) at Week 8 [ Time Frame: Change from baseline in 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).

Eligibility Criteria

Layout table for eligibility information

Ages Eligible for Study:	18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

  Show 45 Study Locations

Sponsors and Collaborators

Forest Laboratories

Investigators

Layout table for investigator information

Study Director:	Carl Gommoll, MS	Forest Laboratories

More Information

Layout table for additonal information

Responsible Party:	Carl Gommoll, Study Director, Forest Laboratories
ClinicalTrials.gov Identifier:	NCT00668525 History of Changes
Other Study ID Numbers:	SCT-MD-49
First Posted:	April 29, 2008
Results First Posted:	May 6, 2010
Last Update Posted:	May 11, 2010
Last Verified:	May 2010

Keywords provided by Forest Laboratories:

Depression; Major Depressive Disorder; Escitalopram

Additional relevant MeSH terms:

Layout table for MeSH terms

Disease; Depressive Disorder; Depression; Depressive Disorder, Major; Pathologic Processes; Mood Disorders; Mental Disorders; Behavioral Symptoms; Citalopram; Dexetimide; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action	Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs; Antidepressive Agents, Second-Generation; Antidepressive Agents; Psychotropic Drugs; Antiparkinson Agents; Anti-Dyskinesia Agents; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents