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
442
1 country
23
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 P50-P75 for phase_3 major-depressive-disorder
Started Dec 2009
23 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
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 16, 2009
CompletedFirst Posted
Study publicly available on registry
December 17, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedResults Posted
Study results publicly available
October 25, 2013
CompletedOctober 25, 2013
August 1, 2013
2 years
December 16, 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)
1
EXPERIMENTALLevomilnacipran ER capsules, flexible dose, oral administration, once daily dosing.
2
PLACEBO COMPARATORMatching placebo capsules, oral administration, once daily dosing.
Interventions
Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing. 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: a. any manic or hypomanic episode; b. schizophrenia or any other psychotic disorder; c. obsessive-compulsive disorder.
- Patients who are considered a suicide risk
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Forest Investigative Site 055
Dothan, Alabama, 36305, United States
Forest Investigative Site 065
Highlands Ranch, Colorado, 80130, United States
Forest Investigative Site 057
Boca Raton, Florida, 33431, United States
Forest Investigative Site 060
Boca Raton, Florida, 33432, United States
Forest Investigative Site 064
Gainesville, Florida, 32607, United States
Forest Investigative Site 053
Ocala, Florida, 34471, United States
Forest Investigative Site 061
Orlando, Florida, 32806, United States
Forest Investigative Site 059
Winter Park, Florida, 32789, United States
Forest Investigative Site 070
Atlanta, Georgia, 30328, United States
Forest Investigative Site 066
Smyrna, Georgia, 30080, United States
Forest Investigative Site 072
Chicago, Illinois, 60634, United States
Forest Investigative Site 050
Oak Brook, Illinois, 60523, United States
Forest Investigative Site 063
Indianapolis, Indiana, 46260, United States
Forest Investigative Site 071
Prairie Village, Kansas, 66206, United States
Forest Investigative Site 052
Shreveport, Louisiana, 71104, United States
Forest Investigative Site 051
Brooklyn, New York, 11214, United States
Forest Investigative Site 056
Oklahoma City, Oklahoma, 73112, United States
Forest Investigative Site 067
Oklahoma City, Oklahoma, 73112, United States
Forest Investigative Site 058
Salem, Oregon, 97301, United States
Forest Investigative Site 054
Allentown, Pennsylvania, 18104, United States
Forest Investigative Site 062
San Antonio, Texas, 78229, United States
Forest Investigative Site 068
Virginia Beach, Virginia, 23452, United States
Forest Investigative Site 069
Spokane, Washington, 99204, United States
Related Publications (3)
Wesnes KA, Gommoll C, Chen C, Sambunaris A, McIntyre RS, Harvey PD. Effects of levomilnacipran extended-release on major depressive disorder patients with cognitive impairments: post-hoc analysis of a phase III study. Int Clin Psychopharmacol. 2017 Mar;32(2):72-79. doi: 10.1097/YIC.0000000000000157.
PMID: 27861191DERIVEDCutler 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: 26644957DERIVEDSambunaris A, Bose A, Gommoll CP, Chen C, Greenberg WM, Sheehan DV. A phase III, double-blind, placebo-controlled, flexible-dose study of levomilnacipran extended-release in patients with major depressive disorder. J Clin Psychopharmacol. 2014 Feb;34(1):47-56. doi: 10.1097/JCP.0000000000000060.
PMID: 24172209DERIVED
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
December 16, 2009
First Posted
December 17, 2009
Study Start
December 1, 2009
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
October 25, 2013
Results First Posted
October 25, 2013
Record last verified: 2013-08