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

August 15, 2012 updated by: Forest Laboratories

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

828

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Dothan, Alabama, United States, 36305
        • Forest Investigative Site 55
    • Arizona
      • Scottsdale, Arizona, United States, 85254
        • Forest Investigative Site 29
    • California
      • Beverly Hills, California, United States, 90210
        • Forest Investigative Site 31
      • Costa Mesa, California, United States, 92626
        • Forest Investigative Site 3
      • Encino, California, United States, 91316
        • Forest Investigative Site 12
      • Escondido, California, United States, 92025
        • Forest Investigative Site 6
      • Oceanside, California, United States, 92056
        • Forest Investigative Site 22
      • Sherman Oaks, California, United States, 91403
        • Forest Investigative Site 38
    • Colorado
      • Denver, Colorado, United States, 80204
        • Forest Investigative Site 36
      • Denver, Colorado, United States, 80239
        • Forest Investigative Site 28
      • Highlands Ranch, Colorado, United States, 80130
        • Forest Investigative Site 65
    • Connecticut
      • Cromwell, Connecticut, United States, 06416
        • Forest Investigative Site 30
    • Florida
      • Boca Raton, Florida, United States, 33431
        • Forest Investigative Site 57
      • Boca Raton, Florida, United States, 33432
        • Forest Investigative Site 60
      • Coral Springs, Florida, United States, 33067
        • Forest Investigative Site 18
      • Fort Myers, Florida, United States, 33912
        • Forest Investigative Site 34
      • Gainesville, Florida, United States, 32607
        • Forest Investigative Site 64
      • Hallandale Beach, Florida, United States, 33009
        • Forest Investigative Site 45
      • Jacksonville, Florida, United States, 32216
        • Forest Investigative Site 17
      • Ocala, Florida, United States, 34471
        • Forest Investigative Site 53
      • Orlando, Florida, United States, 32806
        • Forest Investigative Site 13
      • Orlando, Florida, United States, 32806
        • Forest Investigative Site 61
      • West Palm Beach, Florida, United States, 33407
        • Forest Investigative Site 27
      • Winter Park, Florida, United States, 32789
        • Forest Investigative Site 59
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Forest Investigative Site 70
      • Smyrna, Georgia, United States, 30080
        • Forest Investigative Site 66
    • Illinois
      • Chicago, Illinois, United States, 60634
        • Forest Investigative Site 33
      • Hoffman Estates, Illinois, United States, 60169
        • Forest Investigative Site 23
      • Oak Brook, Illinois, United States, 60523
        • Forest Investigative Site 50
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Forest Investigative Site 63
    • Kansas
      • Prairie Village, Kansas, United States, 66206
        • Forest Investigative Site 71
      • Wichita, Kansas, United States, 67206
        • Forest Investigative Site 5
    • Louisiana
      • Shreveport, Louisiana, United States, 71104
        • Forest Investigative Site 52
    • Maryland
      • Baltimore, Maryland, United States, 21285
        • Forest Investigative Site 1
      • Glen Burnie, Maryland, United States, 21061
        • Forest Investigative Site 2
      • Rockville, Maryland, United States, 20852
        • Forest Investigative Site 37
    • Massachusetts
      • Fall River, Massachusetts, United States, 02721
        • Forest Investigative Site 32
    • Michigan
      • East Lansing, Michigan, United States, 48824
        • Forest Investigative Site 15
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08002
        • Forest Investigative Site 35
      • Willingboro, New Jersey, United States, 08046
        • Forest Investigative Site 21
    • New York
      • Brooklyn, New York, United States, 11214
        • Forest Investigative Site 51
      • Brooklyn, New York, United States, 11235
        • Forest Investigative Site 42
      • Mount Kisco, New York, United States, 10549
        • Forest Investigative Site 4
      • New York, New York, United States, 10003
        • Forest Investigative Site 16
      • New York, New York, United States, 10021
        • Forest Investigative Site 39
      • Staten Island, New York, United States, 10312
        • Forest Investigative Site 9
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Forest Investigative Site 46
    • Ohio
      • Canton, Ohio, United States, 44718
        • Forest Investigative Site 25
      • Dayton, Ohio, United States, 45408
        • Forest Investigative Site 10
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Forest Investigative Site 56
      • Oklahoma City, Oklahoma, United States, 73112
        • Forest Investigative Site 67
    • Oregon
      • Portland, Oregon, United States, 97210
        • Forest Investigative Site 40
      • Salem, Oregon, United States, 97301
        • Forest Investigative Site 58
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Forest Investigative Site 54
      • Media, Pennsylvania, United States, 19063
        • Forest Investigative Site 14
      • Norristown, Pennsylvania, United States, 19401
        • Forest Investigative Site 43
      • Philadelphia, Pennsylvania, United States, 19107
        • Forest Investigative Site 24
    • Rhode Island
      • Lincoln, Rhode Island, United States, 02865
        • Forest Investigative Site 44
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Forest Investigative Site 26
    • Texas
      • Dallas, Texas, United States, 75230
        • Forest Investigative Site 20
      • Dallas, Texas, United States, 75231
        • Forest Investigative Site 47
      • San Antonio, Texas, United States, 78229
        • Forest Investigative Site 62
      • San Antonio, Texas, United States, 78229
        • Forest Investigative Site 7
    • Vermont
      • Woodstock, Vermont, United States, 05091
        • Forest Investigative Site 8
    • Virginia
      • Virginia Beach, Virginia, United States, 23452
        • Forest Investigative Site 68
    • Washington
      • Bellevue, Washington, United States, 98007
        • Forest Investigative Site 19
      • Seattle, Washington, United States, 98104
        • Forest Investigative Site 41
      • Spokane, Washington, United States, 99204
        • Forest Investigative Site 69

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events, clinical laboratory tests, vital sign measurements, electrocardiograms, physical examinations, Columbia-Suicide Severity Rating Scale
Time Frame: 48 weeks
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forest Laboratories

Investigators

  • Study Director: Giovana Forrero, MA, Forest Research Institute, a subsidiary of Forest Laboratories Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

December 16, 2009

First Submitted That Met QC Criteria

December 16, 2009

First Posted (Estimate)

December 17, 2009

Study Record Updates

Last Update Posted (Estimate)

August 17, 2012

Last Update Submitted That Met QC Criteria

August 15, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LVM-MD-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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