Clinical trial NCT01034462: Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder
Official title: A Double-blind, Placebo-Controlled, Flexible-Dose Study of F2695 SR in Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: Depression
Major Depressive Disorder
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2009-12-17
Enrollment: 442
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* 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

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 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

Primary outcomes:
measure: Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
timeFrame: From Baseline to Week 8
Secondary outcomes:
measure: Change in Sheehan Disability Scale (SDS) Total Score
timeFrame: From Baseline to Week 8
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Forest Investigative Site 055
state: Alabama
city: Highlands Ranch
country: United States
facility: Forest Investigative Site 065
state: Colorado
city: Boca Raton
country: United States
facility: Forest Investigative Site 057
state: Florida
city: Boca Raton
country: United States
facility: Forest Investigative Site 060
state: Florida
city: Gainesville
country: United States
facility: Forest Investigative Site 064
state: Florida
city: Ocala
country: United States
facility: Forest Investigative Site 053
state: Florida
city: Orlando
country: United States
facility: Forest Investigative Site 061
state: Florida
city: Winter Park
country: United States
facility: Forest Investigative Site 059
state: Florida
city: Atlanta
country: United States
facility: Forest Investigative Site 070
state: Georgia
city: Smyrna
country: United States
facility: Forest Investigative Site 066
state: Georgia
city: Chicago
country: United States
facility: Forest Investigative Site 072
state: Illinois
city: Oakbrook
country: United States
facility: Forest Investigative Site 050
state: Illinois
city: Indianapolis
country: United States
facility: Forest Investigative Site 063
state: Indiana
city: Prairie Village
country: United States
facility: Forest Investigative Site 071
state: Kansas
city: Shreveport
country: United States
facility: Forest Investigative Site 052
state: Louisiana
city: Brooklyn
country: United States
facility: Forest Investigative Site 051
state: New York
city: Oklahoma City
country: United States
facility: Forest Investigative Site 056
state: Oklahoma
city: Oklahoma City
country: United States
facility: Forest Investigative Site 067
state: Oklahoma
city: Salem
country: United States
facility: Forest Investigative Site 058
state: Oregon
city: Allentown
country: United States
facility: Forest Investigative Site 054
state: Pennsylvania
city: San Antonio
country: United States
facility: Forest Investigative Site 062
state: Texas
city: Virginia Beach
country: United States
facility: Forest Investigative Site 068
state: Virginia
city: Spokane
country: United States
facility: Forest Investigative Site 069
state: Washington
Study officials:
affiliation: Forest Research Institute, a subsidiary of Forest Laboratories Inc.
name: Carl Gommoll, MS
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: Sambunaris 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.