CClinicalTrials.gg
CompletedNCT01034267LVM-MD-04Updated Aug 17, 2012

Safety Study of F2695 SR in Major Depressive Disorder

A Phase 3 interventional study of F2695 SR in Major Depressive Disorder, sponsored by Forest Laboratories. Completed at 68 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-08-17.

Sponsored by Forest Laboratories · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
828
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Major Depressive Disorder

Keywords

  • Depression
  • Major Depressive Disorder
03

In context

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

This study's enrollment of 828 is above the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.

Browse Depressive Disorder studies →

Lead sponsor

Forest Laboratories is the lead sponsor of 165 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
828 participants (actual)

Study arms

  • Experimental
    1

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

    Drug: F2695 SR

Interventions

  • DrugF2695 SR

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

06

What researchers measure

Primary outcomes

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

    Time frame: 48 weeks

07

Study locations

68 sites
  • Forest Investigative Site 55
    Dothan, Alabama 36305, United States
  • Forest Investigative Site 29
    Scottsdale, Arizona 85254, United States
  • Forest Investigative Site 31
    Beverly Hills, California 90210, United States
  • Forest Investigative Site 3
    Costa Mesa, California 92626, United States
  • Forest Investigative Site 12
    Encino, California 91316, United States
  • Forest Investigative Site 6
    Escondido, California 92025, United States
  • Forest Investigative Site 22
    Oceanside, California 92056, United States
  • Forest Investigative Site 38
    Sherman Oaks, California 91403, United States
  • Forest Investigative Site 36
    Denver, Colorado 80204, United States
  • Forest Investigative Site 28
    Denver, Colorado 80239, United States
  • Forest Investigative Site 65
    Highlands Ranch, Colorado 80130, United States
  • Forest Investigative Site 30
    Cromwell, Connecticut 06416, United States
  • Forest Investigative Site 57
    Boca Raton, Florida 33431, United States
  • Forest Investigative Site 60
    Boca Raton, Florida 33432, United States
  • Forest Investigative Site 18
    Coral Springs, Florida 33067, United States
  • Forest Investigative Site 34
    Fort Myers, Florida 33912, United States
  • Forest Investigative Site 64
    Gainesville, Florida 32607, United States
  • Forest Investigative Site 45
    Hallandale Beach, Florida 33009, United States
  • Forest Investigative Site 17
    Jacksonville, Florida 32216, United States
  • Forest Investigative Site 53
    Ocala, Florida 34471, United States
  • Forest Investigative Site 13
    Orlando, Florida 32806, United States
  • Forest Investigative Site 61
    Orlando, Florida 32806, United States
  • Forest Investigative Site 27
    West Palm Beach, Florida 33407, United States
  • Forest Investigative Site 59
    Winter Park, Florida 32789, United States
  • Forest Investigative Site 70
    Atlanta, Georgia 30328, United States
  • Forest Investigative Site 66
    Smyrna, Georgia 30080, United States
  • Forest Investigative Site 33
    Chicago, Illinois 60634, United States
  • Forest Investigative Site 23
    Hoffman Estates, Illinois 60169, United States
  • Forest Investigative Site 50
    Oak Brook, Illinois 60523, United States
  • Forest Investigative Site 63
    Indianapolis, Indiana 46260, United States
  • Forest Investigative Site 71
    Prairie Village, Kansas 66206, United States
  • Forest Investigative Site 5
    Wichita, Kansas 67206, United States
  • Forest Investigative Site 52
    Shreveport, Louisiana 71104, United States
  • Forest Investigative Site 1
    Baltimore, Maryland 21285, United States
  • Forest Investigative Site 2
    Glen Burnie, Maryland 21061, United States
  • Forest Investigative Site 37
    Rockville, Maryland 20852, United States
  • Forest Investigative Site 32
    Fall River, Massachusetts 02721, United States
  • Forest Investigative Site 15
    East Lansing, Michigan 48824, United States
  • Forest Investigative Site 35
    Cherry Hill, New Jersey 08002, United States
  • Forest Investigative Site 21
    Willingboro, New Jersey 08046, United States
  • Forest Investigative Site 51
    Brooklyn, New York 11214, United States
  • Forest Investigative Site 42
    Brooklyn, New York 11235, United States
  • Forest Investigative Site 4
    Mount Kisco, New York 10549, United States
  • Forest Investigative Site 16
    New York, New York 10003, United States
  • Forest Investigative Site 39
    New York, New York 10021, United States
  • Forest Investigative Site 9
    Staten Island, New York 10312, United States
  • Forest Investigative Site 46
    Raleigh, North Carolina 27607, United States
  • Forest Investigative Site 25
    Canton, Ohio 44718, United States
  • Forest Investigative Site 10
    Dayton, Ohio 45408, United States
  • Forest Investigative Site 56
    Oklahoma City, Oklahoma 73112, United States
  • Forest Investigative Site 67
    Oklahoma City, Oklahoma 73112, United States
  • Forest Investigative Site 40
    Portland, Oregon 97210, United States
  • Forest Investigative Site 58
    Salem, Oregon 97301, United States
  • Forest Investigative Site 54
    Allentown, Pennsylvania 18104, United States
  • Forest Investigative Site 14
    Media, Pennsylvania 19063, United States
  • Forest Investigative Site 43
    Norristown, Pennsylvania 19401, United States
  • Forest Investigative Site 24
    Philadelphia, Pennsylvania 19107, United States
  • Forest Investigative Site 44
    Lincoln, Rhode Island 02865, United States
  • Forest Investigative Site 26
    Memphis, Tennessee 38119, United States
  • Forest Investigative Site 20
    Dallas, Texas 75230, United States
  • Forest Investigative Site 47
    Dallas, Texas 75231, United States
  • Forest Investigative Site 62
    San Antonio, Texas 78229, United States
  • Forest Investigative Site 7
    San Antonio, Texas 78229, United States
  • Forest Investigative Site 8
    Woodstock, Vermont 05091, United States
  • Forest Investigative Site 68
    Virginia Beach, Virginia 23452, United States
  • Forest Investigative Site 19
    Bellevue, Washington 98007, United States
  • Forest Investigative Site 41
    Seattle, Washington 98104, United States
  • Forest Investigative Site 69
    Spokane, Washington 99204, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01034267
Lead sponsor
Forest Laboratories
Responsible party
Sponsor
First posted
Dec 17, 2009
Start date
Dec 2009
Primary completion
Jun 2012
Last update
Aug 17, 2012

Study contacts

Giovana Forrero, MA
study director · Forest Research Institute, a subsidiary of Forest Laboratories Inc

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion