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

Phase 3

Completed

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

• Registration Number: NCT01377194
• Lead Sponsor: Forest Laboratories

Brief Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of Levomilnacipran ER compared to placebo in patients with Major Depressive Disorder (MDD).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-10
• Study First Submitted QC: 2011-06-17
• Study First Posted: 2011-06-21
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Disposition First Submitted: 2012-04-27
• Disposition First Submitted QC: 2012-04-27
• Disposition First Posted: 2012-05-01
• 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: 2013-10-29
• Last Update Posted: 2013-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 568

Inclusion Criteria

• Men and women, 18-75 years old
• Currently meet the DSM-IV-TR criteria for Major Depressive Disorder
• The patient's current depressive episode must be at least 6 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 who are considered a suicide risk
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Levomilnacipran ER	40mg Levomilnacipran ER
2	Levomilnacipran ER	80mg of Levomilnacipran ER
3	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score - Mixed-effects Model for Repeated Measures (MMRM) Analysis.	From Baseline to Week 8	The Montgomery-Asberg Depression Rating Scale (MADRS) rates patients 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 was scored on a 7-point scale. A score of 0 indicated the absence of symptoms, and a score of 6 indicated symptoms of maximum severity. The minimum overall score possible was 0 (absence of symptoms), with a maximum overall score of 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 (51)

Forest Investigative Site 039; 🇺🇸 Birmingham, Alabama, United States

Forest Investigative Site 037; 🇺🇸 Beverly Hills, California, United States

Forest Investigative Site 012; 🇺🇸 Encino, California, United States

Forest Investigative Site 038; 🇺🇸 Newport Beach, California, United States

Forest Investigative Site 024; 🇺🇸 Oceanside, California, United States

Forest Investigative Site 001; 🇺🇸 Redlands, California, United States

Forest Investigative Site 031; 🇺🇸 San Diego, California, United States

Forest Investigative Site 050; 🇺🇸 Sherman Oaks, California, United States

Forest Investigative Site 034; 🇺🇸 Cromwell, Connecticut, United States

Forest Investigative Site 021; 🇺🇸 Coral Springs, Florida, United States

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