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Relapse-Prevention Study With F2695 SR in Patients With Major Depressive Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01085812
First received: March 10, 2010
Last updated: December 29, 2011
Last verified: December 2011
History of Changes
  Purpose

The purpose of this study is to evaluate the safety and efficacy of F2695 sustained release (SR) relative to placebo in the prevention of depression relapse in patients with major depressive disorder (MDD).


Condition Intervention Phase
Depression
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 Multicenter, Randomized, Double-blind, Placebo-Controlled, Relapse-Prevention Study With 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:
  • The primary outcome measure is the time to relapse (in days) during the double-blind treatment phase [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]

Enrollment: 348
Study Start Date: March 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2
40, 80 or 120 mg/day F2695 SR capsules, oral administration, once daily dosing.
 Drug: F2695 SR
Drug: F2695 SR (40, 80 or 120 mg/day) Study drug is to be given orally, in capsule form, once daily.
Placebo Comparator: 1
Matching placebo capsules, oral administration, once daily dosing.
 Drug: Placebo
Matching placebo to be given orally, in capsule form, once daily.

Detailed Description:

Patients who demonstrate improvement in depressive symptoms at the end of the initial 12-week open-label treatment period with F2695 SR are randomized to continue F2695 SR or switch to placebo under double-blind conditions for up to 24 weeks of additional treatment.

  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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01085812

  Show 35 Study Locations
Sponsors and Collaborators
Forest Laboratories
Investigators
Study Director: Giovanna Forero, MA Forest Laboratories
  More Information

No publications provided

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01085812     History of Changes
Other Study ID Numbers: LVM-MD-05
Study First Received: March 10, 2010
Last Updated: December 29, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
 Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013