Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder

Phase 3

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: Levomilnacipran ER; Drug: Placebo

• Registration Number: NCT01034462
• Lead Sponsor: Forest Laboratories

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-16
• Study First Submitted QC: 2009-12-16
• Study First Posted: 2009-12-17
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Disposition First Submitted: 2011-12-30
• Disposition First Submitted QC: 2011-12-30
• Disposition First Posted: 2012-01-04
• Status Verified: 2013-08
• Results First Submitted: 2013-08-22
• Results First Submitted QC: 2013-08-22
• Last Update Submitted: 2013-08-22
• Results First Posted: 2013-10-25
• Last Update Posted: 2013-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 442

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Levomilnacipran ER	Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing.
2	Placebo	Matching placebo capsules, oral administration, once daily dosing.

Primary Outcome Measures

Name	Time	Method
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score	From Baseline to Week 8	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).

Secondary Outcome Measures

Name	Time	Method
Change in Sheehan Disability Scale (SDS) Total Score	From Baseline to Week 8	The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe)

Trial Locations

Locations (23)

Forest Investigative Site 068; 🇺🇸 Virginia Beach, Virginia, United States

Forest Investigative Site 057; 🇺🇸 Boca Raton, Florida, United States

Forest Investigative Site 060; 🇺🇸 Boca Raton, Florida, United States

Forest Investigative Site 070; 🇺🇸 Atlanta, Georgia, United States

Forest Investigative Site 059; 🇺🇸 Winter Park, Florida, United States

Forest Investigative Site 065; 🇺🇸 Highlands Ranch, Colorado, United States

Forest Investigative Site 064; 🇺🇸 Gainesville, Florida, United States

Forest Investigative Site 061; 🇺🇸 Orlando, Florida, United States

Forest Investigative Site 071; 🇺🇸 Prairie Village, Kansas, United States

Forest Investigative Site 072; 🇺🇸 Chicago, Illinois, United States

Forest Investigative Site 066; 🇺🇸 Smyrna, Georgia, United States

Forest Investigative Site 051; 🇺🇸 Brooklyn, New York, United States

Forest Investigative Site 069; 🇺🇸 Spokane, Washington, United States

Forest Investigative Site 052; 🇺🇸 Shreveport, Louisiana, United States

Forest Investigative Site 062; 🇺🇸 San Antonio, Texas, United States

Forest Investigative Site 055; 🇺🇸 Dothan, Alabama, United States

Forest Investigative Site 050; 🇺🇸 Oakbrook, Illinois, United States

Forest Investigative Site 056; 🇺🇸 Oklahoma City, Oklahoma, United States

Forest Investigative Site 067; 🇺🇸 Oklahoma City, Oklahoma, United States

Forest Investigative Site 053; 🇺🇸 Ocala, Florida, United States

Forest Investigative Site 054; 🇺🇸 Allentown, Pennsylvania, United States

Forest Investigative Site 058; 🇺🇸 Salem, Oregon, United States

Forest Investigative Site 063; 🇺🇸 Indianapolis, Indiana, United States