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

NCT ID: NCT00969709

Last Updated: 2013-10-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

724 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Brief Summary

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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.

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

40 mg Levomilnacipran ER capsules, low dose, oral administration, once daily.

Group Type EXPERIMENTAL

Levomilnacipran ER

Intervention Type DRUG

Levomilnacipran ER, 40 mg, oral administration, in capsule form, once daily for 8 weeks.

2

80 mg Levomilnacipran ER capsules, medium dose, oral administration, once daily dosing

Group Type EXPERIMENTAL

Levomilnacipran ER

Intervention Type DRUG

Levomilnacipran ER, 80 mg, oral administration, in capsule form, once daily for 8 weeks.

3

120 mg Levomilnacipran ER capsules, high dose, oral administration, once daily dosing

Group Type EXPERIMENTAL

Levomilnacipran ER

Intervention Type DRUG

Levomilnacipran ER, 120 mg, oral administration, in capsule form, once daily for 8 weeks.

4

Matching placebo capsules, oral administration, once daily.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo capsules, oral administration, once daily for 8 weeks.

Interventions

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Levomilnacipran ER

Levomilnacipran ER, 40 mg, oral administration, in capsule form, once daily for 8 weeks.

Intervention Type DRUG

Levomilnacipran ER

Levomilnacipran ER, 80 mg, oral administration, in capsule form, once daily for 8 weeks.

Intervention Type DRUG

Levomilnacipran ER

Levomilnacipran ER, 120 mg, oral administration, in capsule form, once daily for 8 weeks.

Intervention Type DRUG

Placebo

Matching placebo capsules, oral administration, once daily for 8 weeks.

Intervention Type DRUG

Eligibility Criteria

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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
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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Responsibility Role SPONSOR

Principal Investigators

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Carl Gommoll, MS

Role: STUDY_DIRECTOR

Forest Research Institute, a subsidiary of Forest Laboratories Inc.

Locations

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Forest Investigative Site

Phoenix, Arizona, United States

Site Status

Forest Investigative Site

Scottsdale, Arizona, United States

Site Status

Forest Investigative Site

Beverly Hills, California, United States

Site Status

Forest Investigative Site

Costa Mesa, California, United States

Site Status

Forest Investigative Site

Escondido, California, United States

Site Status

Forest Investigative Site

Oceanside, California, United States

Site Status

Forest Investigative Site

Sherman Oaks, California, United States

Site Status

Forest Investigative Site

Denver, Colorado, United States

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Forest Investigative Site

Cromwell, Connecticut, United States

Site Status

Forest Investigative Site

Coral Springs, Florida, United States

Site Status

Forest Investigative Site

Fort Myers, Florida, United States

Site Status

Forest Investigative Site

Hallandale, Florida, United States

Site Status

Forest Investigative Site

Jacksonville, Florida, United States

Site Status

Forest Investigative Site

Orlando, Florida, United States

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Forest Investigative Site

West Palm Beach, Florida, United States

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Forest Investigative Site

Hoffman Estates, Illinois, United States

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Forest Investigative Site

Wichita, Kansas, United States

Site Status

Forest Investigative Site

Baltimore, Maryland, United States

Site Status

Forest Investigative Site

Rockville, Maryland, United States

Site Status

Forest Investigative Site

Cherry Hill, New Jersey, United States

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Forest Investigative Site

Willingboro, New Jersey, United States

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Forest Investigative Site

Brooklyn, New York, United States

Site Status

Forest Investigative Site

Mount Kisco, New York, United States

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Forest Investigative Site

New York, New York, United States

Site Status

Forest Investigative Site

New York, New York, United States

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Forest Investigative Site

Staten Island, New York, United States

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Forest Investigative Site

Raleigh, North Carolina, United States

Site Status

Forest Investigative Site

Canton, Ohio, United States

Site Status

Forest Investigative Site

Portland, Oregon, United States

Site Status

Forest Investigative Site

Media, Pennsylvania, United States

Site Status

Forest Investigative Site

Norristown, Pennsylvania, United States

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Forest Investigative Site

Lincoln, Rhode Island, United States

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Forest Investigative Site

Memphis, Tennessee, United States

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Forest Investigative Site

Dallas, Texas, United States

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Forest Investigative Site

Dallas, Texas, United States

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Forest Investigative Site

San Antonio, Texas, United States

Site Status

Forest Investigative Site

Bellevue, Washington, United States

Site Status

Forest Investigative Site

Seattle, Washington, United States

Site Status

Countries

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United States

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)

Blum SI, Tourkodimitris S, Ruth A. Evaluation of functional health and well-being in patients receiving levomilnacipran ER for the treatment of major depressive disorder. J Affect Disord. 2015 Jan 1;170:230-6. doi: 10.1016/j.jad.2014.09.005. Epub 2014 Sep 10.

Reference Type DERIVED
PMID: 25259674 (View on PubMed)

Asnis GM, Bose A, Gommoll CP, Chen C, Greenberg WM. Efficacy and safety of levomilnacipran sustained release 40 mg, 80 mg, or 120 mg in major depressive disorder: a phase 3, randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2013 Mar;74(3):242-8. doi: 10.4088/JCP.12m08197.

Reference Type DERIVED
PMID: 23561229 (View on PubMed)

Other Identifiers

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LVM-MD-01

Identifier Type: -

Identifier Source: org_study_id