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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
F2695 SR
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Depression, Major Depressive Disorder

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Forest Investigative Site 55
  • Forest Investigative Site 29
  • Forest Investigative Site 31
  • Forest Investigative Site 3
  • Forest Investigative Site 12
  • Forest Investigative Site 6
  • Forest Investigative Site 22
  • Forest Investigative Site 38
  • Forest Investigative Site 36
  • Forest Investigative Site 28
  • Forest Investigative Site 65
  • Forest Investigative Site 30
  • Forest Investigative Site 57
  • Forest Investigative Site 60
  • Forest Investigative Site 18
  • Forest Investigative Site 34
  • Forest Investigative Site 64
  • Forest Investigative Site 45
  • Forest Investigative Site 17
  • Forest Investigative Site 53
  • Forest Investigative Site 13
  • Forest Investigative Site 61
  • Forest Investigative Site 27
  • Forest Investigative Site 59
  • Forest Investigative Site 70
  • Forest Investigative Site 66
  • Forest Investigative Site 33
  • Forest Investigative Site 23
  • Forest Investigative Site 50
  • Forest Investigative Site 63
  • Forest Investigative Site 71
  • Forest Investigative Site 5
  • Forest Investigative Site 52
  • Forest Investigative Site 1
  • Forest Investigative Site 2
  • Forest Investigative Site 37
  • Forest Investigative Site 32
  • Forest Investigative Site 15
  • Forest Investigative Site 35
  • Forest Investigative Site 21
  • Forest Investigative Site 51
  • Forest Investigative Site 42
  • Forest Investigative Site 4
  • Forest Investigative Site 16
  • Forest Investigative Site 39
  • Forest Investigative Site 9
  • Forest Investigative Site 46
  • Forest Investigative Site 25
  • Forest Investigative Site 10
  • Forest Investigative Site 56
  • Forest Investigative Site 67
  • Forest Investigative Site 40
  • Forest Investigative Site 58
  • Forest Investigative Site 54
  • Forest Investigative Site 14
  • Forest Investigative Site 43
  • Forest Investigative Site 24
  • Forest Investigative Site 44
  • Forest Investigative Site 26
  • Forest Investigative Site 20
  • Forest Investigative Site 47
  • Forest Investigative Site 62
  • Forest Investigative Site 7
  • Forest Investigative Site 8
  • Forest Investigative Site 68
  • Forest Investigative Site 19
  • Forest Investigative Site 41
  • Forest Investigative Site 69

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

(Open-label) F2695 SR capsules, oral administration, once daily, flexible dosing

Outcomes

Primary Outcome Measures

Adverse events, clinical laboratory tests, vital sign measurements, electrocardiograms, physical examinations, Columbia-Suicide Severity Rating Scale

Secondary Outcome Measures

Full Information

First Posted
December 16, 2009
Last Updated
August 15, 2012
Sponsor
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT01034267
Brief Title
Safety Study of F2695 SR in Major Depressive Disorder
Acronym
LVM-MD-04
Official Title
A Long-Term, Open-label Extension Study of F2695 SR in Adult Patients With Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forest Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Depression, Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
828 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
(Open-label) F2695 SR capsules, oral administration, once daily, flexible dosing
Intervention Type
Drug
Intervention Name(s)
F2695 SR
Intervention Description
Drug F2695 SR (flexible dose) to be given orally in capsule form once daily
Primary Outcome Measure Information:
Title
Adverse events, clinical laboratory tests, vital sign measurements, electrocardiograms, physical examinations, Columbia-Suicide Severity Rating Scale
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovana Forrero, MA
Organizational Affiliation
Forest Research Institute, a subsidiary of Forest Laboratories Inc
Official's Role
Study Director
Facility Information:
Facility Name
Forest Investigative Site 55
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36305
Country
United States
Facility Name
Forest Investigative Site 29
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85254
Country
United States
Facility Name
Forest Investigative Site 31
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Forest Investigative Site 3
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Forest Investigative Site 12
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Facility Name
Forest Investigative Site 6
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
Forest Investigative Site 22
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Forest Investigative Site 38
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Forest Investigative Site 36
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Forest Investigative Site 28
City
Denver
State/Province
Colorado
ZIP/Postal Code
80239
Country
United States
Facility Name
Forest Investigative Site 65
City
Highlands Ranch
State/Province
Colorado
ZIP/Postal Code
80130
Country
United States
Facility Name
Forest Investigative Site 30
City
Cromwell
State/Province
Connecticut
ZIP/Postal Code
06416
Country
United States
Facility Name
Forest Investigative Site 57
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33431
Country
United States
Facility Name
Forest Investigative Site 60
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33432
Country
United States
Facility Name
Forest Investigative Site 18
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33067
Country
United States
Facility Name
Forest Investigative Site 34
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Forest Investigative Site 64
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Forest Investigative Site 45
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Forest Investigative Site 17
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Forest Investigative Site 53
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Forest Investigative Site 13
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Forest Investigative Site 61
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Forest Investigative Site 27
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Forest Investigative Site 59
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Forest Investigative Site 70
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Forest Investigative Site 66
City
Smyrna
State/Province
Georgia
ZIP/Postal Code
30080
Country
United States
Facility Name
Forest Investigative Site 33
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60634
Country
United States
Facility Name
Forest Investigative Site 23
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Forest Investigative Site 50
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523
Country
United States
Facility Name
Forest Investigative Site 63
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Forest Investigative Site 71
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66206
Country
United States
Facility Name
Forest Investigative Site 5
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67206
Country
United States
Facility Name
Forest Investigative Site 52
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71104
Country
United States
Facility Name
Forest Investigative Site 1
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21285
Country
United States
Facility Name
Forest Investigative Site 2
City
Glen Burnie
State/Province
Maryland
ZIP/Postal Code
21061
Country
United States
Facility Name
Forest Investigative Site 37
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Forest Investigative Site 32
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02721
Country
United States
Facility Name
Forest Investigative Site 15
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States
Facility Name
Forest Investigative Site 35
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08002
Country
United States
Facility Name
Forest Investigative Site 21
City
Willingboro
State/Province
New Jersey
ZIP/Postal Code
08046
Country
United States
Facility Name
Forest Investigative Site 51
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11214
Country
United States
Facility Name
Forest Investigative Site 42
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Forest Investigative Site 4
City
Mount Kisco
State/Province
New York
ZIP/Postal Code
10549
Country
United States
Facility Name
Forest Investigative Site 16
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Forest Investigative Site 39
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Forest Investigative Site 9
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Facility Name
Forest Investigative Site 46
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Forest Investigative Site 25
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Forest Investigative Site 10
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45408
Country
United States
Facility Name
Forest Investigative Site 56
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Forest Investigative Site 67
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Forest Investigative Site 40
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Forest Investigative Site 58
City
Salem
State/Province
Oregon
ZIP/Postal Code
97301
Country
United States
Facility Name
Forest Investigative Site 54
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
Forest Investigative Site 14
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
Forest Investigative Site 43
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19401
Country
United States
Facility Name
Forest Investigative Site 24
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Forest Investigative Site 44
City
Lincoln
State/Province
Rhode Island
ZIP/Postal Code
02865
Country
United States
Facility Name
Forest Investigative Site 26
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Forest Investigative Site 20
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Forest Investigative Site 47
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Forest Investigative Site 62
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Forest Investigative Site 7
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Forest Investigative Site 8
City
Woodstock
State/Province
Vermont
ZIP/Postal Code
05091
Country
United States
Facility Name
Forest Investigative Site 68
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23452
Country
United States
Facility Name
Forest Investigative Site 19
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Forest Investigative Site 41
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Forest Investigative Site 69
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Safety Study of F2695 SR in Major Depressive Disorder

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