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

NCT01377194 | Completed Phase 3 Results

• 1 other identifier: LVM-MD-10
• Study Type: interventional
• Target: 568
• Locations: 2 countries
• Sites: 51

Brief Summary

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).

Conditions

Major Depressive Disorder

Keywords

Depression; Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score - Mixed-effects Model for Repeated Measures (MMRM) Analysis.

  The Montgomery-Asberg Depression Rating Scale (MADRS) rates patients on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item was scored on a 7-point scale. A score of 0 indicated the absence of symptoms, and a score of 6 indicated symptoms of maximum severity. The minimum overall score possible was 0 (absence of symptoms), with a maximum overall score of 60 (maximum severity).

  From Baseline to Week 8

Secondary Outcomes (1)

• Change in Sheehan Disability Scale (SDS) Total Score

  From Baseline to Week 8

Study Arms (3)

1

EXPERIMENTAL

40mg Levomilnacipran ER

Drug: Levomilnacipran ER

2

EXPERIMENTAL

80mg of Levomilnacipran ER

Drug: Levomilnacipran ER

3

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Levomilnacipran ER DRUG

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

1

Placebo DRUG

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

3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Forest Laboratories: lead

Study Sites (51)

Forest Investigative Site 039

Birmingham, Alabama, 35216, United States

Location

Forest Investigative Site 037

Beverly Hills, California, 90210, United States

Location

Forest Investigative Site 012

Encino, California, 91316, United States

Location

Forest Investigative Site 038

Newport Beach, California, 92660, United States

Location

Forest Investigative Site 024

Oceanside, California, 92056, United States

Location

Forest Investigative Site 001

Redlands, California, 92374, United States

Location

Forest Investigative Site 031

San Diego, California, 92108, United States

Location

Forest Investigative Site 050

Sherman Oaks, California, 91403, United States

Location

Forest Investigative Site 034

Cromwell, Connecticut, 06416, United States

Location

Forest Investigative Site 021

Coral Springs, Florida, 33067, United States

Location

Forest Investigative Site 043

Fort Myers, Florida, 33912, United States

Location

Forest Investigative Site 018

Gainesville, Florida, 32607, United States

Location

Forest Investigative Site 060

Hallandale, Florida, 33009, United States

Location

Forest Investigative Site 020

Jacksonville, Florida, 32216, United States

Location

Forest Investigative Site 005

Ocala, Florida, 34471, United States

Location

Forest Investigative Site 014

Orlando, Florida, 32806, United States

Location

Forest Investigative Site 028

Orlando, Florida, 32806, United States

Location

Forest Investigative Site 046

Atlanta, Georgia, 30328, United States

Location

Forest Investigative Site 041

Chicago, Illinois, 60634, United States

Location

Forest Investigative Site 054

Chicago, Illinois, 60640, United States

Location

Forest Investigative Site 026

Hoffman Estates, Illinois, 60169, United States

Location

Forest Investigative Site 045

Indianapolis, Indiana, 46260, United States

Location

Forest Investigative Site 056

Prairie Village, Kansas, 66206, United States

Location

Forest Investigative Site 049

Haverhill, Massachusetts, 01830, United States

Location

Forest Investigative Site 044

Cherry Hill, New Jersey, 08002, United States

Location

Forest Investigative Site 023

Willingboro, New Jersey, 08046, United States

Location

Forest Investigative Site 004

Brooklyn, New York, 11214, United States

Location

Forest Investigative Site 002

Mount Kisco, New York, 10549, United States

Location

Forest Investigative Site 016

New York, New York, 10003, United States

Location

Forest Investigative Site 051

New York, New York, 10021, United States

Location

Forest Investigative Site 042

Orangeburg, New York, 10962, United States

Location

Forest Investigative Site 061

Raleigh, North Carolina, 27607, United States

Location

Forest Investigative Site 010

Dayton, Ohio, 45417, United States

Location

Forest Investigative Site 048

Oklahoma City, Oklahoma, 73112, United States

Location

Forest Investigative Site 053

Portland, Oregon, 97210, United States

Location

Forest Investigative Site 017

Salem, Oregon, 97301, United States

Location

Forest Investigative Site 011

Allentown, Pennsylvania, 18104, United States

Location

Forest Investigative Site 052

Bridgeville, Pennsylvania, 15017, United States

Location

Forest Investigative Site 027

Philadelphia, Pennsylvania, 19107, United States

Location

Forest Investigative Site 059

Lincoln, Rhode Island, 02865, United States

Location

Forest Investigative Site 029

Memphis, Tennessee, 38119, United States

Location

Forest Investigative Site 009

Dallas, Texas, 75231, United States

Location

Forest Investigative Site 007

San Antonio, Texas, 78229, United States

Location

Forest Investigative Site 035

San Antonio, Texas, 78229, United States

Location

Forest Investigative Site 022

Bellevue, Washington, 98007, United States

Location

Forest Investigative Site 055

Seattle, Washington, 98104, United States

Location

Forest Investigative Site 057

Spokane, Washington, 99204, United States

Location

Forest Investigative Site 025

Kelowna, British Columbia, V1Y 1Z9, Canada

Location

Forest Investigative Site 036

Sydney, Nova Scotia, B1S 2EB, Canada

Location

Forest Investigative Site 006

Chatham, Ontario, N7M 1B7, Canada

Location

Forest Investigative Site 003

Ottawa, Ontario, K1G 4G3, Canada

Location

Related Publications (2)

• 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.

  PMID: 26644957 DERIVED

• 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.

  PMID: 24144196 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Levomilnacipran

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Milnacipran; Cyclopropanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Carl Gommoll, MS, Sr. Dir. Clinical Development Psychiatry
• Organization: Forest Research Institute

carl.gommoll@frx.com

201-427-8000

Study Officials

• Carl Gommoll, MS

  Forest Research Institute, a subsidiary of Forest Laboratories

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2011
• First Posted: June 21, 2011
• Study Start: June 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: October 29, 2013
• Results First Posted: October 29, 2013

Record last verified: 2013-08

Locations

US (47); CA (4)