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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00969150
Recruitment Status : Completed
First Posted : September 1, 2009
Results First Posted : October 25, 2013
Last Update Posted : October 25, 2013
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories

Tracking Information
First Submitted Date  ICMJE August 31, 2009
First Posted Date  ICMJE September 1, 2009
Results First Submitted Date  ICMJE August 22, 2013
Results First Posted Date  ICMJE October 25, 2013
Last Update Posted Date October 25, 2013
Study Start Date  ICMJE September 2009
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2013)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: August 31, 2009)
Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 8 weeks ]
Change History Complete list of historical versions of study NCT00969150 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2013)
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)
Original Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2009)
Sheehan Disability Scale (SDS) and Clinical Global Impressions - Improvement (CGI-I) [ Time Frame: 8 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder
Official Title  ICMJE A Double-blind, Placebo-Controlled, Flexible-Dose Study of F2695 SR in Patients With Major Depressive Disorder
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: Levomilnacipran ER
    Drug: Levomilnacipran ER (flexible dose) 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.
Study Arms  ICMJE
  • Placebo Comparator: 2
    Matching placebo capsules, oral administration, once daily dosing.
    Intervention: Drug: Placebo
  • Experimental: 1
    Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing.
    Intervention: Drug: Levomilnacipran ER
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 24, 2011)
362
Original Estimated Enrollment  ICMJE
 (submitted: August 31, 2009)
360
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

    • any manic or hypomanic episode
    • schizophrenia or any other psychotic disorder
    • obsessive-compulsive disorder
  • Patients who are considered a suicide risk
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00969150
Other Study ID Numbers  ICMJE LVM-MD-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Forest Laboratories
Study Sponsor  ICMJE Forest Laboratories
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Carl Gommoll, MS Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
PRS Account Forest Laboratories
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP