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Safety Study of F2695 SR in Major Depressive Disorder (LVM-MD-04)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01034267
First received: December 16, 2009
Last updated: August 15, 2012
Last verified: August 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the long- term safety of F2695-SR in the treatment of adults with major depressive disorder.


Condition Intervention Phase
Major Depressive Disorder
 Drug: F2695 SR
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Long-Term, Open-label Extension Study of F2695 SR in Adult 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:
  • Adverse events, clinical laboratory tests, vital sign measurements, electrocardiograms, physical examinations, Columbia-Suicide Severity Rating Scale [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 828
Study Start Date: December 2009
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
(Open-label) F2695 SR capsules, oral administration, once daily, flexible dosing
 Drug: F2695 SR
Drug F2695 SR (flexible dose) to be given orally in capsule form once daily

  Eligibility

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

Inclusion Criteria:

  • Completed 1 of the lead-in studies LVM-MD-01, LVM-MD-02, or LVM-MD-03
  • Have normal examination findings at the final visit of the lead-in study
  • Have a negative serum pregnancy test at the final visit of the lead-in study if a woman of child-bearing potential

Exclusion Criteria:

  • Any exclusionary psychiatric or medical condition that developed during the lead in study
  • Patients considered a suicide risk
  • Women who are pregnant, breastfeeding, or planning to become during the study OR are sexually active and not currently using a medically acceptable method of contraception
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01034267

  Show 68 Study Locations
Sponsors and Collaborators
Forest Laboratories
Investigators
Study Director: Giovana Forrero, MA Forest Research Institute, a subsidiary of Forest Laboratories Inc
  More Information

No publications provided

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01034267     History of Changes
Other Study ID Numbers: LVM-MD-04
Study First Received: December 16, 2009
Last Updated: August 15, 2012
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