Safety Study of F2695 SR in Major Depressive Disorder
- Conditions
- Major Depressive Disorder
- Interventions
- Drug: F2695 SR
- Registration Number
- NCT01034267
- Lead Sponsor
- Forest Laboratories
- Brief Summary
The purpose of this study is to evaluate the long- term safety of F2695-SR in the treatment of adults with major depressive disorder.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 828
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 F2695 SR (Open-label) F2695 SR capsules, oral administration, once daily, flexible dosing
- Primary Outcome Measures
Name Time Method Adverse events, clinical laboratory tests, vital sign measurements, electrocardiograms, physical examinations, Columbia-Suicide Severity Rating Scale 48 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (68)
Forest Investigative Site 9
🇺🇸Staten Island, New York, United States
Forest Investigative Site 54
🇺🇸Allentown, Pennsylvania, United States
Forest Investigative Site 47
🇺🇸Dallas, Texas, United States
Forest Investigative Site 32
🇺🇸Fall River, Massachusetts, United States
Forest Investigative Site 33
🇺🇸Chicago, Illinois, United States
Forest Investigative Site 41
🇺🇸Seattle, Washington, United States
Forest Investigative Site 55
🇺🇸Dothan, Alabama, United States
Forest Investigative Site 22
🇺🇸Oceanside, California, United States
Forest Investigative Site 29
🇺🇸Scottsdale, Arizona, United States
Forest Investigative Site 31
🇺🇸Beverly Hills, California, United States
Forest Investigative Site 3
🇺🇸Costa Mesa, California, United States
Forest Investigative Site 12
🇺🇸Encino, California, United States
Forest Investigative Site 6
🇺🇸Escondido, California, United States
Forest Investigative Site 60
🇺🇸Boca Raton, Florida, United States
Forest Investigative Site 38
🇺🇸Sherman Oaks, California, United States
Forest Investigative Site 28
🇺🇸Denver, Colorado, United States
Forest Investigative Site 53
🇺🇸Ocala, Florida, United States
Forest Investigative Site 65
🇺🇸Highlands Ranch, Colorado, United States
Forest Investigative Site 30
🇺🇸Cromwell, Connecticut, United States
Forest Investigative Site 57
🇺🇸Boca Raton, Florida, United States
Forest Investigative Site 34
🇺🇸Fort Myers, Florida, United States
Forest Investigative Site 18
🇺🇸Coral Springs, Florida, United States
Forest Investigative Site 59
🇺🇸Winter Park, Florida, United States
Forest Investigative Site 13
🇺🇸Orlando, Florida, United States
Forest Investigative Site 52
🇺🇸Shreveport, Louisiana, United States
Forest Investigative Site 15
🇺🇸East Lansing, Michigan, United States
Forest Investigative Site 61
🇺🇸Orlando, Florida, United States
Forest Investigative Site 27
🇺🇸West Palm Beach, Florida, United States
Forest Investigative Site 23
🇺🇸Hoffman Estates, Illinois, United States
Forest Investigative Site 70
🇺🇸Atlanta, Georgia, United States
Forest Investigative Site 71
🇺🇸Prairie Village, Kansas, United States
Forest Investigative Site 63
🇺🇸Indianapolis, Indiana, United States
Forest Investigative Site 5
🇺🇸Wichita, Kansas, United States
Forest Investigative Site 37
🇺🇸Rockville, Maryland, United States
Forest Investigative Site 1
🇺🇸Baltimore, Maryland, United States
Forest Investigative Site 2
🇺🇸Glen Burnie, Maryland, United States
Forest Investigative Site 42
🇺🇸Brooklyn, New York, United States
Forest Investigative Site 4
🇺🇸Mount Kisco, New York, United States
Forest Investigative Site 16
🇺🇸New York, New York, United States
Forest Investigative Site 25
🇺🇸Canton, Ohio, United States
Forest Investigative Site 39
🇺🇸New York, New York, United States
Forest Investigative Site 46
🇺🇸Raleigh, North Carolina, United States
Forest Investigative Site 14
🇺🇸Media, Pennsylvania, United States
Forest Investigative Site 24
🇺🇸Philadelphia, Pennsylvania, United States
Forest Investigative Site 56
🇺🇸Oklahoma City, Oklahoma, United States
Forest Investigative Site 10
🇺🇸Dayton, Ohio, United States
Forest Investigative Site 67
🇺🇸Oklahoma City, Oklahoma, United States
Forest Investigative Site 40
🇺🇸Portland, Oregon, United States
Forest Investigative Site 58
🇺🇸Salem, Oregon, United States
Forest Investigative Site 62
🇺🇸San Antonio, Texas, United States
Forest Investigative Site 43
🇺🇸Norristown, Pennsylvania, United States
Forest Investigative Site 20
🇺🇸Dallas, Texas, United States
Forest Investigative Site 26
🇺🇸Memphis, Tennessee, United States
Forest Investigative Site 7
🇺🇸San Antonio, Texas, United States
Forest Investigative Site 8
🇺🇸Woodstock, Vermont, United States
Forest Investigative Site 68
🇺🇸Virginia Beach, Virginia, United States
Forest Investigative Site 19
🇺🇸Bellevue, Washington, United States
Forest Investigative Site 44
🇺🇸Lincoln, Rhode Island, United States
Forest Investigative Site 64
🇺🇸Gainesville, Florida, United States
Forest Investigative Site 45
🇺🇸Hallandale Beach, Florida, United States
Forest Investigative Site 66
🇺🇸Smyrna, Georgia, United States
Forest Investigative Site 50
🇺🇸Oak Brook, Illinois, United States
Forest Investigative Site 51
🇺🇸Brooklyn, New York, United States
Forest Investigative Site 21
🇺🇸Willingboro, New Jersey, United States
Forest Investigative Site 69
🇺🇸Spokane, Washington, United States
Forest Investigative Site 36
🇺🇸Denver, Colorado, United States
Forest Investigative Site 17
🇺🇸Jacksonville, Florida, United States
Forest Investigative Site 35
🇺🇸Cherry Hill, New Jersey, United States