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Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

A Double-blind, Placebo-Controlled, Fixed-Dose Study of F2695 SR in Patients With Major Depressive Disorder

NCT00969709•Forest Laboratories

Summary

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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

Locations (38)

Forest Investigative Site

Phoenix, Arizona, United States

Forest Investigative Site

Scottsdale, Arizona, United States

Forest Investigative Site

Beverly Hills, California, United States

Forest Investigative Site

Costa Mesa, California, United States

Forest Investigative Site

Escondido, California, United States

Forest Investigative Site

Oceanside, California, United States

Forest Investigative Site

Sherman Oaks, California, United States

Forest Investigative Site

Denver, Colorado, United States

Forest Investigative Site

Cromwell, Connecticut, United States

Forest Investigative Site

Coral Springs, Florida, United States

Key Dates

Start Date

September 1, 2009

Primary Completion Date

May 1, 2011

Last Updated

October 25, 2013

Enrollment

724

ACTUAL participants

Conditions

Major Depressive Disorder

Interventions

Levomilnacipran ER

DRUG

Levomilnacipran ER

DRUG

Levomilnacipran ER

DRUG

Placebo

DRUG

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

NCT07115329

Major Depressive Disorder

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RECRUITINGPHASE3

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

NCT06793397

Major Depressive Disorder (MDD)Depression in Adults+4 more

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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: March 29, 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.

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

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

Accelerated Intermittent Theta Burst Stimulation for Adolescent and Young Adult Depression With Elevated Suicide Risk

Validating the On-line Creyos Cognitive Assessment Platform in Older Adults With Major Depressive Disorder or Mild Cognitive Impairment

University of Iowa Interventional Psychiatry Service Patient Registry

Optimized Predictive Treatment In Medications for Unipolar Major Depression (OPTIMUM-D)