Safety Study of F2695 SR in Major Depressive Disorder

NCT01034267 | Completed Phase 3

• 1 other identifier: LVM-MD-04
• Study Type: interventional
• Target: 828
• Locations: 1 country
• Sites: 68

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.

Conditions

Major Depressive Disorder

Keywords

Depression; Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

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

  48 weeks

Study Arms (1)

1

EXPERIMENTAL

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

Drug: F2695 SR

Interventions

F2695 SR DRUG

Drug F2695 SR (flexible dose) to be given orally in capsule form once daily

1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Forest Laboratories: lead

Study Sites (68)

Forest Investigative Site 55

Dothan, Alabama, 36305, United States

Location

Forest Investigative Site 29

Scottsdale, Arizona, 85254, United States

Location

Forest Investigative Site 31

Beverly Hills, California, 90210, United States

Location

Forest Investigative Site 3

Costa Mesa, California, 92626, United States

Location

Forest Investigative Site 12

Encino, California, 91316, United States

Location

Forest Investigative Site 6

Escondido, California, 92025, United States

Location

Forest Investigative Site 22

Oceanside, California, 92056, United States

Location

Forest Investigative Site 38

Sherman Oaks, California, 91403, United States

Location

Forest Investigative Site 36

Denver, Colorado, 80204, United States

Location

Forest Investigative Site 28

Denver, Colorado, 80239, United States

Location

Forest Investigative Site 65

Highlands Ranch, Colorado, 80130, United States

Location

Forest Investigative Site 30

Cromwell, Connecticut, 06416, United States

Location

Forest Investigative Site 57

Boca Raton, Florida, 33431, United States

Location

Forest Investigative Site 60

Boca Raton, Florida, 33432, United States

Location

Forest Investigative Site 18

Coral Springs, Florida, 33067, United States

Location

Forest Investigative Site 34

Fort Myers, Florida, 33912, United States

Location

Forest Investigative Site 64

Gainesville, Florida, 32607, United States

Location

Forest Investigative Site 45

Hallandale, Florida, 33009, United States

Location

Forest Investigative Site 17

Jacksonville, Florida, 32216, United States

Location

Forest Investigative Site 53

Ocala, Florida, 34471, United States

Location

Forest Investigative Site 13

Orlando, Florida, 32806, United States

Location

Forest Investigative Site 61

Orlando, Florida, 32806, United States

Location

Forest Investigative Site 27

West Palm Beach, Florida, 33407, United States

Location

Forest Investigative Site 59

Winter Park, Florida, 32789, United States

Location

Forest Investigative Site 70

Atlanta, Georgia, 30328, United States

Location

Forest Investigative Site 66

Smyrna, Georgia, 30080, United States

Location

Forest Investigative Site 33

Chicago, Illinois, 60634, United States

Location

Forest Investigative Site 23

Hoffman Estates, Illinois, 60169, United States

Location

Forest Investigative Site 50

Oak Brook, Illinois, 60523, United States

Location

Forest Investigative Site 63

Indianapolis, Indiana, 46260, United States

Location

Forest Investigative Site 71

Prairie Village, Kansas, 66206, United States

Location

Forest Investigative Site 5

Wichita, Kansas, 67206, United States

Location

Forest Investigative Site 52

Shreveport, Louisiana, 71104, United States

Location

Forest Investigative Site 1

Baltimore, Maryland, 21285, United States

Location

Forest Investigative Site 2

Glen Burnie, Maryland, 21061, United States

Location

Forest Investigative Site 37

Rockville, Maryland, 20852, United States

Location

Forest Investigative Site 32

Fall River, Massachusetts, 02721, United States

Location

Forest Investigative Site 15

East Lansing, Michigan, 48824, United States

Location

Forest Investigative Site 35

Cherry Hill, New Jersey, 08002, United States

Location

Forest Investigative Site 21

Willingboro, New Jersey, 08046, United States

Location

Forest Investigative Site 51

Brooklyn, New York, 11214, United States

Location

Forest Investigative Site 42

Brooklyn, New York, 11235, United States

Location

Forest Investigative Site 4

Mount Kisco, New York, 10549, United States

Location

Forest Investigative Site 16

New York, New York, 10003, United States

Location

Forest Investigative Site 39

New York, New York, 10021, United States

Location

Forest Investigative Site 9

Staten Island, New York, 10312, United States

Location

Forest Investigative Site 46

Raleigh, North Carolina, 27607, United States

Location

Forest Investigative Site 25

Canton, Ohio, 44718, United States

Location

Forest Investigative Site 10

Dayton, Ohio, 45408, United States

Location

Forest Investigative Site 56

Oklahoma City, Oklahoma, 73112, United States

Location

Forest Investigative Site 67

Oklahoma City, Oklahoma, 73112, United States

Location

Forest Investigative Site 40

Portland, Oregon, 97210, United States

Location

Forest Investigative Site 58

Salem, Oregon, 97301, United States

Location

Forest Investigative Site 54

Allentown, Pennsylvania, 18104, United States

Location

Forest Investigative Site 14

Media, Pennsylvania, 19063, United States

Location

Forest Investigative Site 43

Norristown, Pennsylvania, 19401, United States

Location

Forest Investigative Site 24

Philadelphia, Pennsylvania, 19107, United States

Location

Forest Investigative Site 44

Lincoln, Rhode Island, 02865, United States

Location

Forest Investigative Site 26

Memphis, Tennessee, 38119, United States

Location

Forest Investigative Site 20

Dallas, Texas, 75230, United States

Location

Forest Investigative Site 47

Dallas, Texas, 75231, United States

Location

Forest Investigative Site 62

San Antonio, Texas, 78229, United States

Location

Forest Investigative Site 7

San Antonio, Texas, 78229, United States

Location

Forest Investigative Site 8

Woodstock, Vermont, 05091, United States

Location

Forest Investigative Site 68

Virginia Beach, Virginia, 23452, United States

Location

Forest Investigative Site 19

Bellevue, Washington, 98007, United States

Location

Forest Investigative Site 41

Seattle, Washington, 98104, United States

Location

Forest Investigative Site 69

Spokane, Washington, 99204, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Giovana Forrero, MA

  Forest Research Institute, a subsidiary of Forest Laboratories Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2009
• First Posted: December 17, 2009
• Study Start: December 1, 2009
• Primary Completion: June 1, 2012
• Last Updated: August 17, 2012

Record last verified: 2012-08

Locations

US (68)