Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder
A Double-blind, Placebo-Controlled, Flexible-Dose Study of F2695 SR in Patients With Major Depressive Disorder
1 other identifier
interventional
362
1 country
25
Brief Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of Levomilnacipran ER 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 P25-P50 for phase_3 major-depressive-disorder
25 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
November 1, 2010
CompletedResults Posted
Study results publicly available
October 25, 2013
CompletedOctober 25, 2013
August 1, 2013
1.2 years
August 31, 2009
August 22, 2013
August 22, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
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).
From Baseline to Week 8
Secondary Outcomes (1)
Change in Sheehan Disability Scale (SDS) Total Score
From Baseline to Week 8
Study Arms (2)
2
PLACEBO COMPARATORMatching placebo capsules, oral administration, once daily dosing.
1
EXPERIMENTALLevomilnacipran ER capsules, flexible dose, oral administration, once daily dosing.
Interventions
Drug: Levomilnacipran ER (flexible dose) Study drug is to be given orally, in capsule form, once daily, for 8 weeks.
Eligibility Criteria
You may qualify if:
- Men and women, 18-80 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
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 (25)
Forest Investigative Site
Scottsdale, Arizona, 85254, United States
Forest Investigative Site
Encino, California, 91316, United States
Forest Investigative Site
Los Alamitos, California, 90720, United States
Forest Investigative Site
Oceanside, California, 92056, United States
Forest Investigative Site
Denver, Colorado, 80204, United States
Forest Investigative Site
Denver, Colorado, 80239, United States
Forest Investigative Site
Jacksonville, Florida, 32216, United States
Forest Investigative Site
Orlando, Florida, 32806, United States
Forest Investigative Site
Chicago, Illinois, 60634, United States
Forest Investigative Site
Wichita, Kansas, 67206, United States
Forest Investigative Site
Glen Burnie, Maryland, 21061, United States
Forest Investigative Site
Fall River, Massachusetts, 02721, United States
Forest Investigative Site
East Lansing, Michigan, 48824, United States
Forest Investigative Site
Cherry Hill, New Jersey, 08002, United States
Forest Investigative Site
Brooklyn, New York, 11235, 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 013
Canton, Ohio, 44718, United States
Forest Investigative Site
Dayton, Ohio, 45417, United States
Forest Investigative Site
Portland, Oregon, 97210, United States
Forest Investigative Site
Philadelphia, Pennsylvania, 19107, United States
Forest Investigative Site
Lincoln, Rhode Island, 02865, United States
Forest Investigative Site
Woodstock, Vermont, 05091, United States
Forest Investigative Site
Bellevue, Washington, 98007, United States
Forest Investigative Site
Seattle, Washington, 98104, United States
Related Publications (2)
Gommoll CP, Greenberg WM, Chen C. A randomized, double-blind, placebo-controlled study of flexible doses of levomilnacipran ER (40-120 mg/day) in patients with major depressive disorder. J Drug Assess. 2014 Jan 16;3(1):10-9. doi: 10.3109/21556660.2014.884505. eCollection 2014.
PMID: 27536449DERIVEDCutler 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: 26644957DERIVED
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, CARE PROVIDER, 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
November 1, 2010
Last Updated
October 25, 2013
Results First Posted
October 25, 2013
Record last verified: 2013-08