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COMPLETEDPhase 3NCT00969709

Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder

The purpose of this study is to evaluate the efficacy, safety, and tolerability of Levomilnacipran ER fixed doses versus placebo in the treatment of outpatients with major depressive disorder.

Lead sponsor: Forest Laboratories•38 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Forest Laboratories

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Men and women, 18-65 years old
•Currently meet the DSM-IV-TR 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:
•* any manic or hypomanic episode
•* schizophrenia or any other psychotic disorder
•* obsessive-compulsive disorder
•Patients who are considered a suicide risk

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: October 25, 2013Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE3

Enrollment724

Start dateSep 2009

Last updatedOct 25, 2013

Condition

Major Depressive Disorder

Locations shown

Forest Investigative Site

Phoenix, Arizona

Forest Investigative Site

Scottsdale, Arizona

Forest Investigative Site

Beverly Hills, California

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 25, 2013Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions