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Escitalopram in Adult Patients With Major Depressive Disorder

NCT ID: NCT00668525

Last Updated: 2010-05-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

877 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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2

Escitalopram low dose

Group Type ACTIVE_COMPARATOR

Escitalopram

Intervention Type DRUG

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

3

Escitalopram high dose

Group Type EXPERIMENTAL

Escitalopram

Intervention Type DRUG

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

1

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo, oral administration, once daily dosing for 8 weeks

Interventions

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Escitalopram

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

Intervention Type DRUG

Placebo

Placebo, oral administration, once daily dosing for 8 weeks

Intervention Type DRUG

Escitalopram

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Forest Laboratories

INDUSTRY

Sponsor Role lead

Responsible Party

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Forest Laboratories

Principal Investigators

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Carl Gommoll, MS

Role: STUDY_DIRECTOR

Forest Laboratories

Locations

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Forest Investigative Site

Phoenix, Arizona, United States

Site Status

Forest Investigative Site

Arcadia, California, United States

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Forest Investigative Site

Encino, California, United States

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Garden Grove, California, United States

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Irvine, California, United States

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Los Alamitos, California, United States

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Denver, Colorado, United States

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

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Bradenton, Florida, United States

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Jacksonville, Florida, United States

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Orlando, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Newton, Kansas, United States

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Overland, Kansas, United States

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Baltimore, Maryland, United States

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Glen Burnie, Maryland, United States

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Rockville, Maryland, United States

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Okemos, Michigan, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Omaha, Nebraska, United States

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Cherry Hill, New Jersey, United States

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Clementon, New Jersey, United States

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Brooklyn, New York, United States

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New York, New York, United States

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New York, New York, United States

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Staten Island, New York, United States

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The Bronx, New York, United States

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Canton, Ohio, United States

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Dayton, Ohio, United States

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Portland, Oregon, United States

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Media, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Charleston, South Carolina, United States

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Memphis, Tennessee, United States

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Memphis, Tennessee, United States

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Austin, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Woodstock, Vermont, United States

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Richmond, Virginia, United States

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Forest Investigative Site

Bellevue, Washington, United States

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Forest Investigative Site

Seattle, Washington, United States

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Countries

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United States

Other Identifiers

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SCT-MD-49

Identifier Type: -

Identifier Source: org_study_id

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