Escitalopram in Adult Patients With Major Depressive Disorder - Full Text View

Sponsor:	Forest Laboratories
Information provided by:	Forest Laboratories
ClinicalTrials.gov Identifier:	NCT00668525

Purpose

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	Intervention	Phase
Major Depressive Disorder	Drug: Escitalopram Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Double-Blind, Fixed-Dose Study of Escitalopram in Adult Patients With Major Depressive Disorder

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:

Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Hamiltion Rating Scale for Depression (HAM-D) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Estimated Enrollment:	800
Study Start Date:	April 2008
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Active Comparator Escitalopram low dose	Drug: Escitalopram Escitalopram low dose, oral administration, once daily dosing for 8 weeks.
3: Experimental Escitalopram high dose	Drug: Escitalopram Escitalopram high dose, oral administration, once daily dosing for 8 weeks
1: Placebo Comparator Placebo	Drug: Placebo Placebo, oral administration, once daily dosing for 8 weeks

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00668525

Show 45 Study Locations

Sponsors and Collaborators

Forest Laboratories

Investigators

Study Director:

Carl Gommoll, MS

Forest Laboratories

More Information

No publications provided

Responsible Party:	Forest Laboratories ( Carl Gommoll, Study Director )
Study ID Numbers:	SCT-MD-49
Study First Received:	April 28, 2008
Last Updated:	January 22, 2009
ClinicalTrials.gov Identifier:	NCT00668525 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Forest Laboratories:

Depression
Major Depressive Disorder
Escitalopram

Additional relevant MeSH terms:

Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Depressive Disorder, Major
Cholinergic Agents
Pathologic Processes
Mental Disorders
Therapeutic Uses
Dexetimide

Antidepressive Agents, Second-Generation
Antidepressive Agents
Disease
Depression
Depressive Disorder
Serotonin Uptake Inhibitors
Citalopram
Pharmacologic Actions
Behavioral Symptoms
Muscarinic Antagonists
Serotonin Agents
Autonomic Agents
Mood Disorders
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010