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

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).

Full Title of Study: “A Double-blind, Placebo-Controlled, Fixed-Dose Study of Levomilnacipran SR in Patients With Major Depressive Disorder”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 2012

Interventions

  • Drug: Levomilnacipran ER
    • Drug: Levomilnacipran ER 40mg/day Study drug is to be given orally, in capsule form, once daily, for 8 weeks
  • Drug: Levomilnacipran ER
    • Drug: Levomilnacipran ER 80mg/day Study drug is to be given orally, in capsule form, once daily, for 8 weeks
  • Drug: Placebo
    • Matching placebo to be given orally, in capsule form, once daily, for 8 weeks.

Arms, Groups and Cohorts

  • Experimental: 1
    • 40mg Levomilnacipran ER
  • Experimental: 2
    • 80mg of Levomilnacipran ER
  • Placebo Comparator: 3
    • Placebo

Clinical Trial Outcome Measures

Primary Measures

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

  • Change in Sheehan Disability Scale (SDS) Total Score
    • Time Frame: 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)

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Forest Laboratories
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Carl Gommoll, MS, Study Director, Forest Research Institute, a subsidiary of Forest Laboratories

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