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

Forest Laboratories442 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

442

Conditions

Major Depressive Disorder

Interventions

Levomilnacipran ERDRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (23)

Forest Investigative Site 055

Dothan, Alabama, United States

Outcomes

Primary Outcomes

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).

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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