Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder
A Double-blind, Placebo-Controlled, Fixed-Dose Study of F2695 SR in Patients With Major Depressive Disorder
1 other identifier
interventional
724
1 country
38
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 major-depressive-disorder
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2009
CompletedFirst Posted
Study publicly available on registry
September 1, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedResults Posted
Study results publicly available
October 25, 2013
CompletedOctober 25, 2013
August 1, 2013
1.7 years
August 31, 2009
August 22, 2013
August 22, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Montgomery-Ă…sberg Depression Rating Scale (MADRS) Total Score
The MADRS was used to assess depressive symptomatology during the past week. Patients are rated 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 of the 10 items are scored on a 7-point scale. A score of 0 indicates the absence of symptoms,and a score of 6 indicates symptoms of maximum severity. The total MADRS score for this measure ranges from 0 (absence of symptoms) to 60 (maximum severity for all measured symptoms).
From Baseline to Week 8
Secondary Outcomes (1)
Change in Sheehan Disability Scale (SDS) Total Score
From Baseline to Week 8
Study Arms (4)
1
EXPERIMENTAL40 mg Levomilnacipran ER capsules, low dose, oral administration, once daily.
2
EXPERIMENTAL80 mg Levomilnacipran ER capsules, medium dose, oral administration, once daily dosing
3
EXPERIMENTAL120 mg Levomilnacipran ER capsules, high dose, oral administration, once daily dosing
4
PLACEBO COMPARATORMatching placebo capsules, oral administration, once daily.
Interventions
Levomilnacipran ER, 40 mg, oral administration, in capsule form, once daily for 8 weeks.
Eligibility Criteria
You may qualify if:
- 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
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 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
Forest Investigative Site
Phoenix, Arizona, 85020, United States
Forest Investigative Site
Scottsdale, Arizona, 85254, United States
Forest Investigative Site
Beverly Hills, California, 90210, United States
Forest Investigative Site
Costa Mesa, California, 92626, United States
Forest Investigative Site
Escondido, California, 92025, United States
Forest Investigative Site
Oceanside, California, 92056, United States
Forest Investigative Site
Sherman Oaks, California, 91403, United States
Forest Investigative Site
Denver, Colorado, 80239, United States
Forest Investigative Site
Cromwell, Connecticut, 06416, United States
Forest Investigative Site
Coral Springs, Florida, 33067, United States
Forest Investigative Site
Fort Myers, Florida, 33912, United States
Forest Investigative Site
Hallandale, Florida, 33009, United States
Forest Investigative Site
Jacksonville, Florida, 32216, United States
Forest Investigative Site
Orlando, Florida, 32806, United States
Forest Investigative Site
West Palm Beach, Florida, 33407, United States
Forest Investigative Site
Hoffman Estates, Illinois, 60169, United States
Forest Investigative Site
Wichita, Kansas, 67206, United States
Forest Investigative Site
Baltimore, Maryland, 21285, United States
Forest Investigative Site
Rockville, Maryland, 20852, United States
Forest Investigative Site
Cherry Hill, New Jersey, 08002, United States
Forest Investigative Site
Willingboro, New Jersey, 08046, United States
Forest Investigative Site
Brooklyn, New York, 11235, United States
Forest Investigative Site
Mount Kisco, New York, 10549, United States
Forest Investigative Site
New York, New York, 10003, United States
Forest Investigative Site
New York, New York, 10021, United States
Forest Investigative Site
Staten Island, New York, 10312, United States
Forest Investigative Site
Raleigh, North Carolina, 27607, United States
Forest Investigative Site
Canton, Ohio, 44718, United States
Forest Investigative Site
Portland, Oregon, 97210, United States
Forest Investigative Site
Media, Pennsylvania, 19063, United States
Forest Investigative Site
Norristown, Pennsylvania, 19403, United States
Forest Investigative Site
Lincoln, Rhode Island, 02865, United States
Forest Investigative Site
Memphis, Tennessee, 38119, United States
Forest Investigative Site
Dallas, Texas, 75230, United States
Forest Investigative Site
Dallas, Texas, 75231, United States
Forest Investigative Site
San Antonio, Texas, 78229, United States
Forest Investigative Site
Bellevue, Washington, 98007, United States
Forest Investigative Site
Seattle, Washington, 98104, United States
Related Publications (3)
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: 26644957DERIVEDBlum 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.
PMID: 25259674DERIVEDAsnis 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.
PMID: 23561229DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Carl Gommoll, MS, Sr. Dir. Clinical Development Psychiatry
- Organization
- Forest Research Institute
Study Officials
- STUDY DIRECTOR
Carl Gommoll, MS
Forest Research Institute, a subsidiary of Forest Laboratories Inc.
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
August 31, 2009
First Posted
September 1, 2009
Study Start
September 1, 2009
Primary Completion
May 1, 2011
Last Updated
October 25, 2013
Results First Posted
October 25, 2013
Record last verified: 2013-08