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Safety and Efficacy of F2695 SR in Major Depressive Disorder

This study has been completed.
Sponsor:
Information provided by:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00969709
First received: August 31, 2009
Last updated: July 8, 2011
Last verified: July 2011
History of Changes
  Purpose

The purpose of this study is to evaluate the efficacy, safety, and tolerability of F2695 SR fixed doses 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, Fixed-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: 724
Study Start Date: September 2009
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
F2695 SR capsules, low dose, oral administration, once daily dosing.
 Drug: F2695 SR
F2695 SR, low dose, oral administration, in capsule form, once daily for 8 weeks.
Experimental: 2
F2695 SR capsules, medium dose, oral administration, once daily dosing
 Drug: F2695 SR
F2695 SR, medium dose, oral administration, in capsule form, once daily for 8 weeks.
Experimental: 3
120 mg/day F2695 SR capsules, high dose, oral administration, once daily dosing
 Drug: F2695 SR
F2695 SR, high dose, oral administration, in capsule form, once daily for 8 weeks.
Placebo Comparator: 4
Matching placebo capsules, oral administration, once daily dosing.
 Drug: Placebo
Matching placebo capsules, oral administration, once daily for 8 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women, 18-65 years old
  • Currently meet the DSM-IV-TR criteria for Major Depressive Disorder
  • The patient's current depressive episode must be at least 8 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00969709

  Show 38 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: Anjana Bose, Exec. Dir., Clinical Develop Psychiatry, Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00969709     History of Changes
Other Study ID Numbers: LVM-MD-01
Study First Received: August 31, 2009
Last Updated: July 8, 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 16, 2013