Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 20 of 6156 for:    "Depressive Disorder" [DISEASE]

Safety and Efficacy of Levomilnacipran ER (Levomilnacipran 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: NCT01377194
Recruitment Status : Completed
First Posted : June 21, 2011
Results First Posted : October 29, 2013
Last Update Posted : October 29, 2013
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories

Tracking Information
First Submitted Date  ICMJE June 10, 2011
First Posted Date  ICMJE June 21, 2011
Results First Submitted Date  ICMJE August 22, 2013
Results First Posted Date  ICMJE October 29, 2013
Last Update Posted Date October 29, 2013
Study Start Date  ICMJE June 2011
Actual Primary Completion Date March 2012   (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 - 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).
Original Primary Outcome Measures  ICMJE
 (submitted: June 17, 2011)
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) at Week 8 [ Time Frame: Baseline to Week 8 ]
Change History Complete list of historical versions of study NCT01377194 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: June 17, 2011)
Change from Baseline in Sheehan Disability Scale (SDS) at Week 8 [ Time Frame: Baseline to Week 8 ]
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 (Levomilnacipran SR) in Major Depressive Disorder
Official Title  ICMJE A Double-blind, Placebo-Controlled, Fixed-Dose Study of Levomilnacipran 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 compared to placebo in patients with Major Depressive Disorder (MDD).
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, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: 1
    40mg Levomilnacipran ER
    Intervention: Drug: Levomilnacipran ER
  • Experimental: 2
    80mg of Levomilnacipran ER
    Intervention: Drug: Levomilnacipran ER
  • Placebo Comparator: 3
    Placebo
    Intervention: Drug: Placebo
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: August 22, 2013)
568
Original Estimated Enrollment  ICMJE
 (submitted: June 17, 2011)
510
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 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 Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01377194
Other Study ID Numbers  ICMJE LVM-MD-10
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
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