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

  Hide Study Locations
Locations
United States, Alabama
Forest Investigative Site 55
Dothan, Alabama, United States, 36305
United States, Arizona
Forest Investigative Site 29
Scottsdale, Arizona, United States, 85254
United States, California
Forest Investigative Site 31
Beverly Hills, California, United States, 90210
Forest Investigative Site 3
Costa Mesa, California, United States, 92626
Forest Investigative Site 12
Encino, California, United States, 91316
Forest Investigative Site 6
Escondido, California, United States, 92025
Forest Investigative Site 22
Oceanside, California, United States, 92056
Forest Investigative Site 38
Sherman Oaks, California, United States, 91403
United States, Colorado
Forest Investigative Site 28
Denver, Colorado, United States, 80239
Forest Investigative Site 36
Denver, Colorado, United States, 80204
Forest Investigative Site 65
Highlands Ranch, Colorado, United States, 80130
United States, Connecticut
Forest Investigative Site 30
Cromwell, Connecticut, United States, 06416
United States, Florida
Forest Investigative Site 60
Boca Raton, Florida, United States, 33432
Forest Investigative Site 57
Boca Raton, Florida, United States, 33431
Forest Investigative Site 18
Coral Springs, Florida, United States, 33067
Forest Investigative Site 34
Fort Myers, Florida, United States, 33912
Forest Investigative Site 64
Gainesville, Florida, United States, 32607
Forest Investigative Site 45
Hallandale Beach, Florida, United States, 33009
Forest Investigative Site 17
Jacksonville, Florida, United States, 32216
Forest Investigative Site 53
Ocala, Florida, United States, 34471
Forest Investigative Site 61
Orlando, Florida, United States, 32806
Forest Investigative Site 13
Orlando, Florida, United States, 32806
Forest Investigative Site 27
West Palm Beach, Florida, United States, 33407
Forest Investigative Site 59
Winter Park, Florida, United States, 32789
United States, Georgia
Forest Investigative Site 70
Atlanta, Georgia, United States, 30328
Forest Investigative Site 66
Smyrna, Georgia, United States, 30080
United States, Illinois
Forest Investigative Site 33
Chicago, Illinois, United States, 60634
Forest Investigative Site 23
Hoffman Estates, Illinois, United States, 60169
Forest Investigative Site 50
Oak Brook, Illinois, United States, 60523
United States, Indiana
Forest Investigative Site 63
Indianapolis, Indiana, United States, 46260
United States, Kansas
Forest Investigative Site 71
Prairie Village, Kansas, United States, 66206
Forest Investigative Site 5
Wichita, Kansas, United States, 67206
United States, Louisiana
Forest Investigative Site 52
Shreveport, Louisiana, United States, 71104
United States, Maryland
Forest Investigative Site 1
Baltimore, Maryland, United States, 21285
Forest Investigative Site 2
Glen Burnie, Maryland, United States, 21061
Forest Investigative Site 37
Rockville, Maryland, United States, 20852
United States, Massachusetts
Forest Investigative Site 32
Fall River, Massachusetts, United States, 02721
United States, Michigan
Forest Investigative Site 15
East Lansing, Michigan, United States, 48824
United States, New Jersey
Forest Investigative Site 35
Cherry Hill, New Jersey, United States, 08002
Forest Investigative Site 21
Willingboro, New Jersey, United States, 08046
United States, New York
Forest Investigative Site 42
Brooklyn, New York, United States, 11235
Forest Investigative Site 51
Brooklyn, New York, United States, 11214
Forest Investigative Site 4
Mount Kisco, New York, United States, 10549
Forest Investigative Site 16
New York, New York, United States, 10003
Forest Investigative Site 39
New York, New York, United States, 10021
Forest Investigative Site 9
Staten Island, New York, United States, 10312
United States, North Carolina
Forest Investigative Site 46
Raleigh, North Carolina, United States, 27607
United States, Ohio
Forest Investigative Site 25
Canton, Ohio, United States, 44718
Forest Investigative Site 10
Dayton, Ohio, United States, 45408
United States, Oklahoma
Forest Investigative Site 67
Oklahoma City, Oklahoma, United States, 73112
Forest Investigative Site 56
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
Forest Investigative Site 40
Portland, Oregon, United States, 97210
Forest Investigative Site 58
Salem, Oregon, United States, 97301
United States, Pennsylvania
Forest Investigative Site 54
Allentown, Pennsylvania, United States, 18104
Forest Investigative Site 14
Media, Pennsylvania, United States, 19063
Forest Investigative Site 43
Norristown, Pennsylvania, United States, 19401
Forest Investigative Site 24
Philadelphia, Pennsylvania, United States, 19107
United States, Rhode Island
Forest Investigative Site 44
Lincoln, Rhode Island, United States, 02865
United States, Tennessee
Forest Investigative Site 26
Memphis, Tennessee, United States, 38119
United States, Texas
Forest Investigative Site 20
Dallas, Texas, United States, 75230
Forest Investigative Site 47
Dallas, Texas, United States, 75231
Forest Investigative Site 7
San Antonio, Texas, United States, 78229
Forest Investigative Site 62
San Antonio, Texas, United States, 78229
United States, Vermont
Forest Investigative Site 8
Woodstock, Vermont, United States, 05091
United States, Virginia
Forest Investigative Site 68
Virginia Beach, Virginia, United States, 23452
United States, Washington
Forest Investigative Site 19
Bellevue, Washington, United States, 98007
Forest Investigative Site 41
Seattle, Washington, United States, 98104
Forest Investigative Site 69
Spokane, Washington, United States, 99204
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 August 28, 2014