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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01034267
First Posted: December 17, 2009
Last Update Posted: August 17, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Forest Laboratories
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Long-Term, Open-label Extension Study of F2695 SR in Adult Patients With Major Depressive Disorder

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01034267     History of Changes
Other Study ID Numbers: LVM-MD-04
First Submitted: December 16, 2009
First Posted: December 17, 2009
Last Update Posted: August 17, 2012
Last Verified: August 2012

Keywords provided by Forest Laboratories:
Depression
Major Depressive Disorder

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