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

NCT ID: NCT01377194

Last Updated: 2013-10-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

568 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-03-31

Brief Summary

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The purpose of this study is to evaluate the efficacy, safety, and tolerability of Levomilnacipran ER compared to placebo in patients with Major Depressive Disorder (MDD).

Detailed Description

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Conditions

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Major Depressive Disorder

Keywords

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Depression 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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1

40mg Levomilnacipran ER

Group Type EXPERIMENTAL

Levomilnacipran ER

Intervention Type DRUG

Drug: Levomilnacipran ER 40mg/day Study drug is to be given orally, in capsule form, once daily, for 8 weeks

2

80mg of Levomilnacipran ER

Group Type EXPERIMENTAL

Levomilnacipran ER

Intervention Type DRUG

Drug: Levomilnacipran ER 80mg/day Study drug is to be given orally, in capsule form, once daily, for 8 weeks

3

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo to be given orally, in capsule form, once daily, for 8 weeks.

Interventions

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Levomilnacipran ER

Drug: Levomilnacipran ER 40mg/day Study drug is to be given orally, in capsule form, once daily, for 8 weeks

Intervention Type DRUG

Levomilnacipran ER

Drug: Levomilnacipran ER 80mg/day Study drug is to be given orally, in capsule form, once daily, for 8 weeks

Intervention Type DRUG

Placebo

Matching placebo to be given orally, in capsule form, once daily, for 8 weeks.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Men and women, 18-75 years old
* Currently meet the DSM-IV-TR criteria for Major Depressive Disorder
* The patient's current depressive episode must be at least 6 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 who are considered a suicide risk
* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 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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Responsibility Role SPONSOR

Principal Investigators

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Carl Gommoll, MS

Role: STUDY_DIRECTOR

Forest Research Institute, a subsidiary of Forest Laboratories

Locations

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Forest Investigative Site 039

Birmingham, Alabama, United States

Site Status

Forest Investigative Site 037

Beverly Hills, California, United States

Site Status

Forest Investigative Site 012

Encino, California, United States

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Forest Investigative Site 038

Newport Beach, California, United States

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Forest Investigative Site 024

Oceanside, California, United States

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Forest Investigative Site 001

Redlands, California, United States

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Forest Investigative Site 031

San Diego, California, United States

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Forest Investigative Site 050

Sherman Oaks, California, United States

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Forest Investigative Site 034

Cromwell, Connecticut, United States

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Forest Investigative Site 021

Coral Springs, Florida, United States

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Forest Investigative Site 043

Fort Myers, Florida, United States

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Forest Investigative Site 018

Gainesville, Florida, United States

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Forest Investigative Site 060

Hallandale, Florida, United States

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Forest Investigative Site 020

Jacksonville, Florida, United States

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Forest Investigative Site 005

Ocala, Florida, United States

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Forest Investigative Site 014

Orlando, Florida, United States

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Forest Investigative Site 028

Orlando, Florida, United States

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Forest Investigative Site 046

Atlanta, Georgia, United States

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Forest Investigative Site 041

Chicago, Illinois, United States

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Forest Investigative Site 054

Chicago, Illinois, United States

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Forest Investigative Site 026

Hoffman Estates, Illinois, United States

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Forest Investigative Site 045

Indianapolis, Indiana, United States

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Forest Investigative Site 056

Prairie Village, Kansas, United States

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Forest Investigative Site 049

Haverhill, Massachusetts, United States

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Forest Investigative Site 044

Cherry Hill, New Jersey, United States

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Forest Investigative Site 023

Willingboro, New Jersey, United States

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Forest Investigative Site 004

Brooklyn, New York, United States

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Forest Investigative Site 002

Mount Kisco, New York, United States

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Forest Investigative Site 016

New York, New York, United States

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Forest Investigative Site 051

New York, New York, United States

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Forest Investigative Site 042

Orangeburg, New York, United States

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Forest Investigative Site 061

Raleigh, North Carolina, United States

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Forest Investigative Site 010

Dayton, Ohio, United States

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Forest Investigative Site 048

Oklahoma City, Oklahoma, United States

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Forest Investigative Site 053

Portland, Oregon, United States

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Forest Investigative Site 017

Salem, Oregon, United States

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Forest Investigative Site 011

Allentown, Pennsylvania, United States

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Forest Investigative Site 052

Bridgeville, Pennsylvania, United States

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Forest Investigative Site 027

Philadelphia, Pennsylvania, United States

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Forest Investigative Site 059

Lincoln, Rhode Island, United States

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Forest Investigative Site 029

Memphis, Tennessee, United States

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Forest Investigative Site 009

Dallas, Texas, United States

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Forest Investigative Site 007

San Antonio, Texas, United States

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Forest Investigative Site 035

San Antonio, Texas, United States

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Forest Investigative Site 022

Bellevue, Washington, United States

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Forest Investigative Site 055

Seattle, Washington, United States

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Forest Investigative Site 057

Spokane, Washington, United States

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Forest Investigative Site 025

Kelowna, British Columbia, Canada

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Forest Investigative Site 036

Sydney, Nova Scotia, Canada

Site Status

Forest Investigative Site 006

Chatham, Ontario, Canada

Site Status

Forest Investigative Site 003

Ottawa, Ontario, Canada

Site Status

Countries

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United States Canada

References

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Cutler AJ, Gommoll CP, Chen C, Greenberg WM, Ruth A. Levomilnacipran Extended-Release Treatment in Patients With Major Depressive Disorder: Improvements in Functional Impairment Categories. Prim Care Companion CNS Disord. 2015 Jun 11;17(3):10.4088/PCC.14m01753. doi: 10.4088/PCC.14m01753. eCollection 2015.

Reference Type DERIVED
PMID: 26644957 (View on PubMed)

Bakish D, Bose A, Gommoll C, Chen C, Nunez R, Greenberg WM, Liebowitz M, Khan A. Levomilnacipran ER 40 mg and 80 mg in patients with major depressive disorder: a phase III, randomized, double-blind, fixed-dose, placebo-controlled study. J Psychiatry Neurosci. 2014 Jan;39(1):40-9. doi: 10.1503/jpn.130040.

Reference Type DERIVED
PMID: 24144196 (View on PubMed)

Other Identifiers

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LVM-MD-10

Identifier Type: -

Identifier Source: org_study_id