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A Multicenter, Relapse Prevention Study With Levomilnacipran ER in Patients With Major Depressive Disorder

Information source: Forest Laboratories
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Depressive Disorder, Major

Intervention: Levomilnacipran ER (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Forest Laboratories

Official(s) and/or principal investigator(s):
Rezwanur Rahman, Study Director, Affiliation: Forest Laboratories, a subsidiary of Actavis plc.

Overall contact:
Rebecca Atwell, Phone: 866-369-5227, Ext: 8112, Email: Rebecca.Atwell@actavis.com

Summary

This study evaluates the efficacy, safety and tolerability of levomilnacipran extended-release (ER) compared with placebo in the prevention of depression relapse (MDD).

Clinical Details

Official title: A Multicenter, Randomized, Double-blind, Placebo-Controlled, Relapse Prevention Study With Levomilnacipran ER in Patients With Major Depressive Disorder

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Time to first relapse measured in days during the double-blind treatment period.

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Men and Women 18-70

- Currently meet the DSM-V criteria for Major Depressive Disorder (MDD)

- The patient must have an ongoing major depressive episode of at least 8 weeks and no

more than 18 months

- The patient must have at least 3 lifetime episodes of MDD (including the current

episode) 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

- History of non-response to 2 or more antidepressants (after adequate treatment)

- Patients who have a history of meeting The Diagnostic and Statistical Manual of

Mental Disorders, Fifth Edition (DSM-5) criteria for manic, hypomanic, or mixed episodes schizophrenia or other psychotic disorder obsessive-compulsive disorder

- Panic disorder

Locations and Contacts

Rebecca Atwell, Phone: 866-369-5227, Ext: 8112, Email: Rebecca.Atwell@actavis.com

Forest Investigative Site 053, Birmingham, Alabama 35294, United States; Recruiting

Forest Investigative Site 050, Dothan, Alabama 36303, United States; Recruiting

Forest Investigative Site 039, Phoenix, Arizona 85032, United States; Recruiting

Forest Investigative Site 048, Beverly Hills, California 90210, United States; Recruiting

Forest Investigative Site 047, Chino, California 91710, United States; Terminated

Forest Investigative Site 028, Costa Mesa, California 92626, United States; Recruiting

Forest Investigative Site 021, Encino, California 91316, United States; Recruiting

Forest Investigative Site 052, Escondido, California 92025, United States; Recruiting

Forest Investigative Site 025, Newport Beach, California 92660, United States; Withdrawn

Forest Investigative Site 042, Oceanside, California 92056, United States; Recruiting

Forest Investigative Site 024, Redlands, California 92374, United States; Withdrawn

Forest Investigative Site 016, Sherman Oaks, California 91403, United States; Recruiting

Forest Investigative Site 037, Sherman Oaks, California 91403, United States; Recruiting

Forest Investigative Site 043, Simi Valley, California 91360, United States; Recruiting

Forest Investigative Site 040, Cromwell, Connecticut 06475, United States; Recruiting

Forest Investigative Site 038, Norwich, Connecticut 06360, United States; Recruiting

Forest Investigative Site 023, Bradenton, Florida 34201, United States; Recruiting

Forest Investigative Site 006, Coral Springs, Florida 33067, United States; Withdrawn

Forest Investigative Site 018, Fort Myers, Florida 33912, United States; Recruiting

Forest Investigative Site 002, Hallandale Beach, Florida 33009, United States; Withdrawn

Forest Investigative Site 008, Jacksonville Beach, Florida 32250, United States; Recruiting

Forest Investigative Site 001, Jacksonville, Florida 32256, United States; Recruiting

Forest Investigative Site 057, Kissimmee, Florida 34741, United States; Recruiting

Forest Investigative Site 009, Orlando, Florida 32801, United States; Recruiting

Forest Investigative Site 045, West Palm Beach, Florida 33407, United States; Recruiting

Forest Investigative Site 034, Alpharetta, Georgia 30005, United States; Recruiting

Forest Investigative Site 049, Smyrna, Georgia 30080, United States; Recruiting

Forest Investigative Site 019, Schaumburg, Illinois 60194, United States; Recruiting

Forest Investigative Site 029, Skokie, Illinois 60076, United States; Withdrawn

Forest Investigative Site 027, Lafayette, Indiana 47905, United States; Withdrawn

Forest Investigative Site 020, Methuen, Massachusetts 01844, United States; Recruiting

Forest Investigative Site 017, Roslindale, Massachusetts 02131, United States; Withdrawn

Forest Investigative Site 051, Watertown, Massachusetts 02472, United States; Recruiting

Forest Investigative Site 044, Cherry Hill, New Jersey 08002, United States; Recruiting

Forest Investigative Site 007, Brooklyn, New York 11214, United States; Withdrawn

Forest Investigative Site 031, Brooklyn, New York 11235, United States; Recruiting

Forest Investigative Site 036, Cedarhurst, New York 11516, United States; Recruiting

Forest Investigative Site 013, Mt. Kisco, New York 10549, United States; Recruiting

Forest Investigative Site 003, New York, New York 10003, United States; Recruiting

Forest Investigative Site 005, New York, New York 10168, United States; Recruiting

Forest Investigative Site 055, Rochester, New York 14618, United States; Recruiting

Forest Investigative Site 058, Charlotte, North Carolina 28204, United States; Recruiting

Forest Investigative Site 011, Dayton, Ohio 45417, United States; Recruiting

Forest Investigative Site 004, Oklahoma City, Oklahoma 73103, United States; Withdrawn

Forest Investigative Site 035, Tulsa, Oklahoma 74104, United States; Recruiting

Forest Investigative Site 046, Portland, Oregon 97210, United States; Recruiting

Forest Investigative Site 041, Salem, Oregon 97301, United States; Recruiting

Forest Investigative Site 032, Allentown, Pennsylvania 18104, United States; Withdrawn

Forest Investigative Site 012, Media, Pennsylvania 19063, United States; Recruiting

Forest Investigative Site 030, Memphis, Tennessee 38119, United States; Recruiting

Forest Investigative Site 033, Memphis, Tennessee 38119, United States; Recruiting

Forest Investigative Site 054, Dallas, Texas 75243, United States; Recruiting

Forest Investigative Site 059, Houston, Texas 77090, United States; Recruiting

Forest Investigative Site 014, Murray, Utah 84123, United States; Recruiting

Forest Investigative Site 010, Charlottesville, Virginia 22911, United States; Terminated

Forest Investigative Site 056, Roanoke, Virginia 24014, United States; Recruiting

Forest Investigative Site 015, Bellevue, Washington 98007, United States; Withdrawn

Forest Investigative Site 026, Brown Deer, Wisconsin 53223, United States; Recruiting

Forest Investigative Site 022, Middleton, Wisconsin 53562, United States; Withdrawn

Additional Information

Starting date: November 2014
Last updated: July 30, 2015

Page last updated: August 23, 2015

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