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Relapse-Prevention Study With Levomilnacipran ER (F2695 SR) in Patients With Major Depressive Disorder

NCT ID: NCT01085812

Last Updated: 2020-01-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

734 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-10-31

Brief Summary

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The purpose of this study is to evaluate the safety and efficacy of Levomilnacipran ER relative to placebo in the prevention of depression relapse in patients with major depressive disorder (MDD).

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Detailed Description

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Patients who demonstrate improvement in depressive symptoms at the end of the initial 12-week open-label treatment period with Levomilnacipran ER are randomized to continue Levomilnacipran ER or switch to placebo under double-blind conditions for up to 24 weeks of additional treatment.

Conditions

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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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2

40, 80 or 120 mg/day Levomilnacipran ER capsules, oral administration, once daily dosing.

Group Type EXPERIMENTAL

Levomilnacipran ER

Intervention Type DRUG

Drug: Levomilnacipran ER (40, 80 or 120 mg/day) Study drug is to be given orally, in capsule form, once daily.

1

Matching placebo capsules, oral administration, once daily dosing.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Levomilnacipran ER

Drug: Levomilnacipran ER (40, 80 or 120 mg/day) Study drug is to be given orally, in capsule form, once daily.

Intervention Type DRUG

Placebo

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

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 4 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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Giovanna Forero, MA

Role: STUDY_DIRECTOR

Forest Laboratories

Locations

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Forest Investigative Site #023

Beverly Hills, California, United States

Site Status

Forest Investigative Site #017

Encino, California, United States

Site Status

Forest Investigative Site #021

Garden Grove, California, United States

Site Status

Forest Investigative Site #025

Newport Beach, California, United States

Site Status

Forest Investigative Site #030

Orange, California, United States

Site Status

Forest Investigative Site #002

San Diego, California, United States

Site Status

Forest Investigative Site #003

Sherman Oaks, California, United States

Site Status

Forest Research Institute #001

Bonita Springs, Florida, United States

Site Status

Forest Investigative Site #015

Fort Myers, Florida, United States

Site Status

Forest Investigative Site #029

Maitland, Florida, United States

Site Status

Forest Investigative Site #005

North Miami, Florida, United States

Site Status

Forest Investigative Site #016

Orlando, Florida, United States

Site Status

Forest Investigative Site #004

South Miami, Florida, United States

Site Status

Forest Investigative Site #014

Atlanta, Georgia, United States

Site Status

Forest Investigative Site #022

Chicago, Illinois, United States

Site Status

Forest Investigative Site #006

Chicago, Illinois, United States

Site Status

Forest Investigative Site #009

Prairie Village, Kansas, United States

Site Status

Forest Investigative Site #013

Baltimore, Maryland, United States

Site Status

Forest Investigative Site #010

Boston, Massachusetts, United States

Site Status

Forest Investigative Site #012

St Louis, Missouri, United States

Site Status

Forest Investigative Site #011

Staten Island, New York, United States

Site Status

Forest Investigative Site #026

Portland, Oregon, United States

Site Status

Forest Investigative Site #008

Bridgeville, Pennsylvania, United States

Site Status

Forest Investigative Site #028

Norristown, Pennsylvania, United States

Site Status

Forest Investigative Site #020

Philadelphia, Pennsylvania, United States

Site Status

Forest Investigative Site #024

Memphis, Tennessee, United States

Site Status

Forest Investigative Site #007

Dallas, Texas, United States

Site Status

Forest Investigative Site #019

San Antonio, Texas, United States

Site Status

Forest Investigative Site #018

Bellevue, Washington, United States

Site Status

Forest Investigative Site #027

Seattle, Washington, United States

Site Status

Forest Investigative Site #050

Kelowna, British Columbia, Canada

Site Status

Forest Investigative Site #051

Vancouver, British Columbia, Canada

Site Status

Forest Investigative Site #052

Sydney, Nova Scotia, Canada

Site Status

Forest Investigative Site #055

Chatham, Ontario, Canada

Site Status

Forest Investigative Site #053

Ottawa, Ontario, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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LVM-MD-05

Identifier Type: -

Identifier Source: org_study_id

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