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

Forest Laboratories568 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

568

Conditions

Major Depressive Disorder

Interventions

Levomilnacipran ERDRUG

Drug: Levomilnacipran ER 40mg/day Study drug is to be given orally, in capsule form, once daily, for 8 weeks

Levomilnacipran ERDRUG

Drug: Levomilnacipran ER 80mg/day Study drug is to be given orally, in capsule form, once daily, for 8 weeks

PlaceboDRUG

Matching placebo to be given orally, in capsule form, once daily, for 8 weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (51)

Outcomes

Primary Outcomes

Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score - Mixed-effects Model for Repeated Measures (MMRM) Analysis.

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).

Time frame: From Baseline to Week 8

Secondary Outcomes

Change in Sheehan Disability Scale (SDS) Total Score

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)

Time frame: From Baseline to Week 8

Data from ClinicalTrials.gov

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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

...and 41 more locations