Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

December 16, 2009
August 15, 2012
December 2009
June 2012   (final data collection date for primary outcome measure)
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 ]
Adverse events, clinical laboratory rests, vital sign measurements, electrocardiograms, physical examinations, Columbia-Suicide Severity Rating Scale [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01034267 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety Study of F2695 SR in Major Depressive Disorder
A Long-Term, Open-label Extension Study of F2695 SR in Adult Patients With Major Depressive Disorder

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

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Major Depressive Disorder
Drug: F2695 SR
Drug F2695 SR (flexible dose) to be given orally in capsule form once daily
Experimental: 1
(Open-label) F2695 SR capsules, oral administration, once daily, flexible dosing
Intervention: Drug: F2695 SR
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
828
Not Provided
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01034267
LVM-MD-04
No
Forest Laboratories
Forest Laboratories
Not Provided
Study Director: Giovana Forrero, MA Forest Research Institute, a subsidiary of Forest Laboratories Inc
Forest Laboratories
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP