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Safety and Efficacy of F2695 SR in Major Depressive Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01034462
First received: December 16, 2009
Last updated: December 30, 2011
Last verified: December 2011
History of Changes
  Purpose

The purpose of this study is to evaluate the efficacy, safety, and tolerability of F2695 SR versus placebo in the treatment of outpatients with major depressive disorder


Condition Intervention Phase
Major Depressive Disorder
 Drug: F2695 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, Flexible-Dose Study of F2695 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:
  • Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sheehan Disability Scale (SDS) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 442
Study Start Date: December 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
F2695 SR capsules, flexible dose, oral administration, once daily dosing.
 Drug: F2695 SR
F2695 SR capsules, flexible dose, oral administration, once daily dosing. Study drug is to be given orally, in capsule form, once daily, for 8 weeks
Placebo Comparator: 2
Matching placebo capsules, oral administration, once daily dosing.
 Drug: Placebo
Matching placebo to be given orally, in capsule form, once daily, for 8 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01034462

  Show 23 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

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01034462     History of Changes
Other Study ID Numbers: LVM-MD-03
Study First Received: December 16, 2009
Last Updated: December 30, 2011
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

ClinicalTrials.gov processed this record on May 23, 2013