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

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 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Double-blind, Fixed-dose Study of Escitalopram in Adult Patients With Major Depressive Disorder

Resource links provided by NLM:

Drug Information available for: Citalopram hydrobromide Citalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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:

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 ] [ Designated as safety issue: No ]
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).


Enrollment:	877
Study Start Date:	April 2008
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (Adult)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


Responsible Party:	Carl Gommoll, Study Director, Forest Laboratories
ClinicalTrials.gov Identifier:	NCT00668525 History of Changes
Other Study ID Numbers:	SCT-MD-49
Study First Received:	April 28, 2008
Results First Received:	March 22, 2010
Last Updated:	May 7, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Forest Laboratories:


Depression Major Depressive Disorder Escitalopram

Additional relevant 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

ClinicalTrials.gov processed this record on September 27, 2016