Study of Escitalopram in Adult Patients With Major Depressive Disorder

NCT ID: NCT00108979

Last Updated: 2012-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2006-07-31

Brief Summary

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Escitalopram is the S-enantiomer of citalopram. Both escitalopram and citalopram are selective serotonin reuptake inhibitors (SSRIs) and are used to treat depression in adults. This study is designed to evaluate the efficacy, safety, and pharmacoeconomics of escitalopram and an active comparator in patients with major depressive disorder.

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

DOUBLE

Interventions

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Escitalopram

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients must meet Diagnostic and Statistical Manual, Fourth Edition (DSM-IV) diagnostic criteria for Major Depressive Disorder.
* The patient's current depressive episode must be at least 12 weeks in duration.

Exclusion Criteria

* Women who are pregnant, women who will be breastfeeding during the study, and women of childbearing potential who are not practicing a reliable method of birth control.
* Patients who currently meet DSM-IV criteria for: a. bipolar disorder; b. schizophrenia or any psychotic disorder; c. obsessive-compulsive disorder; d. mental retardation or any pervasive developmental disorder or cognitive disorder.
* Patients who are considered a suicide risk.
* Patients with a history of seizure disorder, or any history of seizure, stroke, significant head injury, or any other condition that predisposes toward risk of seizure.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Forest Laboratories

INDUSTRY

Sponsor Role lead

Locations

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Southwest Health, Ltd.

Phoenix, Arizona, United States

Site Status

Summit Research Network

Okemos, Michigan, United States

Site Status

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

Summit Research Network

Portland, Oregon, United States

Site Status

CNS Research Institute

Philadelphia, Pennsylvania, United States

Site Status

Clinical Neuroscience Solutions

Memphis, Tennessee, United States

Site Status

Radiant Research

Salt Lake City, Utah, United States

Site Status

Northwest Clinical Research Center

Bellevue, Washington, United States

Site Status

Summit Research Network

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Signorovitch J, Ramakrishnan K, Ben-Hamadi R, Yu AP, Wu EQ, Dworak H, Erder MH. Remission of major depressive disorder without adverse events: a comparison of escitalopram versus serotonin norepinephrine reuptake inhibitors. Curr Med Res Opin. 2011 Jun;27(6):1089-96. doi: 10.1185/03007995.2011.567255. Epub 2011 Mar 28.

Reference Type DERIVED
PMID: 21438794 (View on PubMed)

Other Identifiers

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SCT-MD-23

Identifier Type: -

Identifier Source: org_study_id

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