Clinical trial NCT01034267: Safety Study of F2695 SR in Major Depressive Disorder
Official title: A Long-Term, Open-label Extension Study of F2695 SR in Adult Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: Depression
Major Depressive Disorder
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2009-12-17
Enrollment: 828
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Adverse events, clinical laboratory tests, vital sign measurements, electrocardiograms, physical examinations, Columbia-Suicide Severity Rating Scale
timeFrame: 48 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Forest Investigative Site 55
state: Alabama
city: Scottsdale
country: United States
facility: Forest Investigative Site 29
state: Arizona
city: Beverly Hills
country: United States
facility: Forest Investigative Site 31
state: California
city: Costa Mesa
country: United States
facility: Forest Investigative Site 3
state: California
city: Encino
country: United States
facility: Forest Investigative Site 12
state: California
city: Escondido
country: United States
facility: Forest Investigative Site 6
state: California
city: Oceanside
country: United States
facility: Forest Investigative Site 22
state: California
city: Sherman Oaks
country: United States
facility: Forest Investigative Site 38
state: California
city: Denver
country: United States
facility: Forest Investigative Site 36
state: Colorado
city: Denver
country: United States
facility: Forest Investigative Site 28
state: Colorado
city: Highlands Ranch
country: United States
facility: Forest Investigative Site 65
state: Colorado
city: Cromwell
country: United States
facility: Forest Investigative Site 30
state: Connecticut
city: Boca Raton
country: United States
facility: Forest Investigative Site 57
state: Florida
city: Boca Raton
country: United States
facility: Forest Investigative Site 60
state: Florida
city: Coral Springs
country: United States
facility: Forest Investigative Site 18
state: Florida
city: Fort Myers
country: United States
facility: Forest Investigative Site 34
state: Florida
city: Gainesville
country: United States
facility: Forest Investigative Site 64
state: Florida
city: Hallandale Beach
country: United States
facility: Forest Investigative Site 45
state: Florida
city: Jacksonville
country: United States
facility: Forest Investigative Site 17
state: Florida
city: Ocala
country: United States
facility: Forest Investigative Site 53
state: Florida
city: Orlando
country: United States
facility: Forest Investigative Site 13
state: Florida
city: Orlando
country: United States
facility: Forest Investigative Site 61
state: Florida
city: West Palm Beach
country: United States
facility: Forest Investigative Site 27
state: Florida
city: Winter Park
country: United States
facility: Forest Investigative Site 59
state: Florida
city: Atlanta
country: United States
facility: Forest Investigative Site 70
state: Georgia
city: Smyrna
country: United States
facility: Forest Investigative Site 66
state: Georgia
city: Chicago
country: United States
facility: Forest Investigative Site 33
state: Illinois
city: Hoffman Estates
country: United States
facility: Forest Investigative Site 23
state: Illinois
city: Oak Brook
country: United States
facility: Forest Investigative Site 50
state: Illinois
city: Indianapolis
country: United States
facility: Forest Investigative Site 63
state: Indiana
city: Prairie Village
country: United States
facility: Forest Investigative Site 71
state: Kansas
city: Wichita
country: United States
facility: Forest Investigative Site 5
state: Kansas
city: Shreveport
country: United States
facility: Forest Investigative Site 52
state: Louisiana
city: Baltimore
country: United States
facility: Forest Investigative Site 1
state: Maryland
city: Glen Burnie
country: United States
facility: Forest Investigative Site 2
state: Maryland
city: Rockville
country: United States
facility: Forest Investigative Site 37
state: Maryland
city: Fall River
country: United States
facility: Forest Investigative Site 32
state: Massachusetts
city: East Lansing
country: United States
facility: Forest Investigative Site 15
state: Michigan
city: Cherry Hill
country: United States
facility: Forest Investigative Site 35
state: New Jersey
city: Willingboro
country: United States
facility: Forest Investigative Site 21
state: New Jersey
city: Brooklyn
country: United States
facility: Forest Investigative Site 51
state: New York
city: Brooklyn
country: United States
facility: Forest Investigative Site 42
state: New York
city: Mount Kisco
country: United States
facility: Forest Investigative Site 4
state: New York
city: New York
country: United States
facility: Forest Investigative Site 16
state: New York
city: New York
country: United States
facility: Forest Investigative Site 39
state: New York
city: Staten Island
country: United States
facility: Forest Investigative Site 9
state: New York
city: Raleigh
country: United States
facility: Forest Investigative Site 46
state: North Carolina
city: Canton
country: United States
facility: Forest Investigative Site 25
state: Ohio
city: Dayton
country: United States
facility: Forest Investigative Site 10
state: Ohio
city: Oklahoma City
country: United States
facility: Forest Investigative Site 56
state: Oklahoma
city: Oklahoma City
country: United States
facility: Forest Investigative Site 67
state: Oklahoma
city: Portland
country: United States
facility: Forest Investigative Site 40
state: Oregon
city: Salem
country: United States
facility: Forest Investigative Site 58
state: Oregon
city: Allentown
country: United States
facility: Forest Investigative Site 54
state: Pennsylvania
city: Media
country: United States
facility: Forest Investigative Site 14
state: Pennsylvania
city: Norristown
country: United States
facility: Forest Investigative Site 43
state: Pennsylvania
city: Philadelphia
country: United States
facility: Forest Investigative Site 24
state: Pennsylvania
city: Lincoln
country: United States
facility: Forest Investigative Site 44
state: Rhode Island
city: Memphis
country: United States
facility: Forest Investigative Site 26
state: Tennessee
city: Dallas
country: United States
facility: Forest Investigative Site 20
state: Texas
city: Dallas
country: United States
facility: Forest Investigative Site 47
state: Texas
city: San Antonio
country: United States
facility: Forest Investigative Site 62
state: Texas
city: San Antonio
country: United States
facility: Forest Investigative Site 7
state: Texas
city: Woodstock
country: United States
facility: Forest Investigative Site 8
state: Vermont
city: Virginia Beach
country: United States
facility: Forest Investigative Site 68
state: Virginia
city: Bellevue
country: United States
facility: Forest Investigative Site 19
state: Washington
city: Seattle
country: United States
facility: Forest Investigative Site 41
state: Washington
city: Spokane
country: United States
facility: Forest Investigative Site 69
state: Washington
Study officials:
affiliation: Forest Research Institute, a subsidiary of Forest Laboratories Inc
name: Giovana Forrero, MA
role: STUDY_DIRECTOR
References: