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

August 15, 2012 updated by: Forest Laboratories

A Long-Term, Open-label Extension Study of F2695 SR in Adult Patients With Major Depressive Disorder

The purpose of this study is to evaluate the long- term safety of F2695-SR in the treatment of adults with major depressive disorder.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
828

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1
(Open-label) F2695 SR capsules, oral administration, once daily, flexible dosing
Drug: F2695 SR
Drug F2695 SR (flexible dose) to be given orally in capsule form once daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Adverse events, clinical laboratory tests, vital sign measurements, electrocardiograms, physical examinations, Columbia-Suicide Severity Rating Scale
Time Frame: 48 weeks
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Forest Laboratories

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Giovana Forrero, MA, Forest Research Institute, a subsidiary of Forest Laboratories Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 17, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 17, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LVM-MD-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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