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Safety and Efficacy of Levomilnacipran SR in Major Depressive Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01377194
First received: June 10, 2011
Last updated: April 27, 2012
Last verified: April 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the efficacy, safety, and tolerability of Levomilnacipran SR compared to placebo in patients with Major Depressive Disorder (MDD).


Condition Intervention Phase
Major Depressive Disorder
 Drug: Levomilnacipran SR
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 Levomilnacipran SR in Patients With Major Depressive Disorder

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by Forest Laboratories:

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

Secondary Outcome Measures:
  • Change from Baseline in Sheehan Disability Scale (SDS) at Week 8 [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]

Enrollment: 571
Study Start Date: June 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
40mg Levomilnacipran SR
 Drug: Levomilnacipran SR
Drug: Levomilnacipran SR 40mg/day Study drug is to be given orally, in capsule form, once daily, for 8 weeks
Experimental: 2
80mg of Levomilnacipran SR
 Drug: Levomilnacipran SR
Drug: Levomilnacipran SR 80mg/day Study drug is to be given orally, in capsule form, once daily, for 8 weeks
Placebo Comparator: 3
Placebo
 Drug: Placebo
Matching placebo to be given orally, in capsule form, once daily, for 8 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01377194

  Show 51 Study Locations
Sponsors and Collaborators
Forest Laboratories
Investigators
Study Director: Carl Gommoll, MS Forest Research Institute, a subsidiary of Forest Laboratories
  More Information

No publications provided

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01377194     History of Changes
Other Study ID Numbers: LVM-MD-10
Study First Received: June 10, 2011
Last Updated: April 27, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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

ClinicalTrials.gov processed this record on June 13, 2013