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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00969709
First received: August 31, 2009
Last updated: August 22, 2013
Last verified: August 2013
  Purpose

The purpose of this study is to evaluate the efficacy, safety, and tolerability of Levomilnacipran ER fixed doses versus placebo in the treatment of outpatients with major depressive disorder.


Condition Intervention Phase
Major Depressive Disorder
Drug: Levomilnacipran ER
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-Controlled, Fixed-Dose Study of F2695 SR in Patients With Major Depressive Disorder

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score [ Time Frame: From Baseline to Week 8 ] [ Designated as safety issue: No ]

    The 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 for all measured symptoms).



Secondary Outcome Measures:
  • Change in Sheehan Disability Scale (SDS) Total Score [ Time Frame: From Baseline to Week 8 ] [ Designated as safety issue: No ]
    The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate functional 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 for all measured symptoms)


Enrollment: 724
Study Start Date: September 2009
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
40 mg Levomilnacipran ER capsules, low dose, oral administration, once daily.
Drug: Levomilnacipran ER
Levomilnacipran ER, 40 mg, oral administration, in capsule form, once daily for 8 weeks.
Experimental: 2
80 mg Levomilnacipran ER capsules, medium dose, oral administration, once daily dosing
Drug: Levomilnacipran ER
Levomilnacipran ER, 80 mg, oral administration, in capsule form, once daily for 8 weeks.
Experimental: 3
120 mg Levomilnacipran ER capsules, high dose, oral administration, once daily dosing
Drug: Levomilnacipran ER
Levomilnacipran ER, 120 mg, oral administration, in capsule form, once daily for 8 weeks.
Placebo Comparator: 4
Matching placebo capsules, oral administration, once daily.
Drug: Placebo
Matching placebo capsules, oral administration, once daily for 8 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women, 18-65 years old
  • Currently meet the DSM-IV-TR criteria for Major Depressive Disorder
  • The patient's current depressive episode must be at least 8 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:

    • any manic or hypomanic episode
    • schizophrenia or any other psychotic disorder
    • obsessive-compulsive disorder
  • Patients who are considered a suicide risk
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00969709

  Show 38 Study Locations
Sponsors and Collaborators
Forest Laboratories
Investigators
Study Director: Carl Gommoll, MS Forest Research Institute, a subsidiary of Forest Laboratories Inc.
  More Information

No publications provided by Forest Laboratories

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00969709     History of Changes
Other Study ID Numbers: LVM-MD-01
Study First Received: August 31, 2009
Results First Received: August 22, 2013
Last Updated: August 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Forest Laboratories:
Depression
Major Depressive Disorder

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Milnacipran
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents

ClinicalTrials.gov processed this record on July 26, 2014