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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014