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Completed

NCT Number: NCT01034462

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

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

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Forest Investigative Site 055, Dothan, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levomilnacipran ER

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

    Time frame: From Baseline to Week 8

    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).

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Registry information

Official study title

A Double-blind, Placebo-Controlled, Flexible-Dose Study of F2695 SR in Patients With Major Depressive Disorder

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Dec 17, 2009
Registry last updated
Oct 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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