Major Depressive DisorderPhase 3LVM-MD-04NCT01034267

Safety Study of F2695 SR in Major Depressive Disorder

A Phase 3 study testing F2695 SR in people with Major Depressive Disorder, run by Forest Laboratories at 68 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Major Depressive Disorder
What is being tested?: F2695 SR
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 828 participants
Where: 68 sitesUnited States
Study dates: Dec 2009to Jun 2012
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

68 sites in 1 country.

City, postcode or hospital

68 sites in 1 country

United States68 sites

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

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About this study

Official title: 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.

Conditions: Major Depressive Disorder
Being tested: F2695 SR
Keywords: Depression, Major Depressive Disorder
Medical subject headings: Depressive Disorder, Major, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01034267
Study group	Role	What they receive
1	Experimental	(Open-label) F2695 SR capsules, oral administration, once daily, flexible dosing Receives: Drug: F2695 SR

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse events, clinical laboratory tests, vital sign measurements, electrocardiograms, physical examinations, Columbia-Suicide Severity Rating Scale
Measured: 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2009Jun 2012

First posted17 Dec 2009 (estimated)
Study startDec 2009
Primary completionJun 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 828 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01034267
Sponsor's protocol ID: LVM-MD-04
Acronym: LVM-MD-04
Status last verified: Aug 2012
First submitted: 16 Dec 2009
Last updated: 17 Aug 2012
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Long-Term, Open-label Extension Study of F2695 SR in Adult Patients With Major Depressive Disorder
ClinicalTrials.gov ID: NCT01034267
Acronym / sponsor ID: LVM-MD-04 / LVM-MD-04
Conditions: Major Depressive Disorder
Keywords: Depression, Major Depressive Disorder
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 828 participants (actual)
Lead sponsor: Forest LaboratoriesIndustry (pharma, biotech, devices)
Study start: Dec 2009
Primary completion: Jun 2012 (actual)
First posted: 17 Dec 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Drug: F2695 SR(Open-label) F2695 SR capsules, oral administration, once daily, flexible dosing

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
F2695 SRDrug F2695 SR (flexible dose) to be given orally in capsule form once daily	Drug	1

Primary outcome

Adverse events, clinical laboratory tests, vital sign measurements, electrocardiograms, physical examinations, Columbia-Suicide Severity Rating Scale
Time frame: 48 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2012.

Related trials for Major Depressive Disorder

Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Giovana Forrero, MA study director

Forest Research Institute, a subsidiary of Forest Laboratories Inc

68 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing F2695 SR in people with Major Depressive Disorder, run by Forest Laboratories at 68 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events, clinical laboratory tests, vital sign measurements, electrocardiograms, physical examinations, Columbia-Suicide Severity Rating Scale (time frame: 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01034267.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2012.