DepressionPhase 3NCT01085812

Relapse-Prevention Study With Levomilnacipran ER (F2695 SR) in Patients With Major Depressive Disorder

A Phase 3 study testing Levomilnacipran ER in people with Depression and Major Depressive Disorder, run by Forest Laboratories at 35 sites in 2 countries.

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 safety and efficacy of Levomilnacipran ER relative to placebo in the prevention of depression relapse in patients with major depressive disorder (MDD). Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Depression, Major Depressive Disorder
What is being tested?: Levomilnacipran ER
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 734 participants
Where: 35 sitesin 2 countries
Study dates: Mar 2010to Oct 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Men and women, 18-65 years old
Currently meet the DSM-IV-TR criteria for Major Depressive Disorder
The patient's current depressive episode must be at least 4 weeks in duration

Who cannot join

Women who are pregnant, women who will be breastfeeding during the study, and women with childbearing potential who are not practicing a reliable method of birth control
Patients with a history of meeting DSM-IV-TR criteria for:
any manic or hypomanic episode
schizophrenia or any other psychotic disorder
obsessive-compulsive disorder
Patients who are considered a suicide risk

Trial locations and contacts

35 sites in 2 countries.

Country

City, postcode or hospital

35 sites in 2 countries

United States30 sites

Forest Investigative Site #014
Atlanta, Georgia, 30328
Forest Investigative Site #013
Baltimore, Maryland, 21208
Forest Investigative Site #018
Bellevue, Washington, 98007
Forest Investigative Site #023
Beverly Hills, California, 90210
Forest Research Institute #001
Bonita Springs, Florida, 34134
Forest Investigative Site #010
Boston, Massachusetts, 02135
Forest Investigative Site #008
Bridgeville, Pennsylvania, 15017
Forest Investigative Site #022
Chicago, Illinois, 60634
Forest Investigative Site #006
Chicago, Illinois, 60640
Forest Investigative Site #007
Dallas, Texas, 75231
Forest Investigative Site #017
Encino, California, 31316
Forest Investigative Site #015
Fort Myers, Florida, 33912
Forest Investigative Site #021
Garden Grove, California, 92845
Forest Investigative Site #029
Maitland, Florida, 32751
Forest Investigative Site #024
Memphis, Tennessee, 38119
Forest Investigative Site #025
Newport Beach, California, 92660
Forest Investigative Site #028
Norristown, Pennsylvania, 19401
Forest Investigative Site #005
North Miami, Florida, 33161
Forest Investigative Site #030
Orange, California, 92868
Forest Investigative Site #016
Orlando, Florida, 32806
Forest Investigative Site #020
Philadelphia, Pennsylvania, 19139
Forest Investigative Site #026
Portland, Oregon, 97210
Forest Investigative Site #009
Prairie Village, Kansas, 66206
Forest Investigative Site #019
San Antonio, Texas, 78229
Forest Investigative Site #002
San Diego, California, 92108
Forest Investigative Site #027
Seattle, Washington, 98104
Forest Investigative Site #003
Sherman Oaks, California, 91403
Forest Investigative Site #004
South Miami, Florida, 33143
Forest Investigative Site #012
St Louis, Missouri, 63139
Forest Investigative Site #011
Staten Island, New York, 10312

Other trials in United States

Canada5 sites

Forest Investigative Site #055
Chatham, Ontario, N7M 1B7
Forest Investigative Site #050
Kelowna, British Columbia, V1Y 1Z9
Forest Investigative Site #053
Ottawa, Ontario, K1G 4G3
Forest Investigative Site #052
Sydney, Nova Scotia, B1S 2E8
Forest Investigative Site #051
Vancouver, British Columbia, V6Z 2L4

Other trials in Canada

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-Controlled, Relapse-Prevention Study With F2695 SR in Patients With Major Depressive Disorder

The purpose of this study is to evaluate the safety and efficacy of Levomilnacipran ER relative to placebo in the prevention of depression relapse in patients with major depressive disorder (MDD).

Read the detailed description

Patients who demonstrate improvement in depressive symptoms at the end of the initial 12-week open-label treatment period with Levomilnacipran ER are randomized to continue Levomilnacipran ER or switch to placebo under double-blind conditions for up to 24 weeks of additional treatment.

Conditions: Depression, Major Depressive Disorder
Being tested: Levomilnacipran ER, Placebo
Medical subject headings: Depression, Depressive Disorder, Major

What participants receive

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

Levomilnacipran ERDrug
Drug: Levomilnacipran ER (40, 80 or 120 mg/day) Study drug is to be given orally, in capsule form, once daily.
PlaceboDrug
Matching placebo to be given orally, in capsule form, once daily.

Study groups in NCT01085812
Study group	Role	What they receive
2	Experimental	40, 80 or 120 mg/day Levomilnacipran ER capsules, oral administration, once daily dosing. Receives: Drug: Levomilnacipran ER
1	Placebo comparator	Matching placebo capsules, oral administration, once daily dosing. Receives: Drug: Placebo

What is being measured

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

Time to Relapse (Days)
Number of days until patients meet relapse criteria. Relapse was defined as 1 or more of the following: 1. MADRS total score of at least 22 at 2 consecutive visits 2. Increase of 2 or more points in CGI-I score compared with the CGI-I score at Visit 9 at 2 consecutive visits 3. Premature discontinuation due to insufficient therapeutic response 4. MADRS item 10 score of at least 4
Measured: 24 Weeks

Timeline

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

Mar 2010Oct 2011

First posted12 Mar 2010 (estimated)
Study startMar 2010
Primary completionOct 2011
Study completionOct 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DepressionStudies 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: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 734 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01085812
Sponsor's protocol ID: LVM-MD-05
Status last verified: Dec 2019
First submitted: 10 Mar 2010
Last updated: 13 Jan 2020
Results posted: Yes, on ClinicalTrials.gov
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?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-blind, Placebo-Controlled, Relapse-Prevention Study With F2695 SR in Patients With Major Depressive Disorder
ClinicalTrials.gov ID: NCT01085812
Acronym / sponsor ID: LVM-MD-05
Conditions: Depression, Major Depressive Disorder
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 734 participants (actual)
Lead sponsor: Forest LaboratoriesIndustry (pharma, biotech, devices)
Study start: Mar 2010
Primary completion: Oct 2011 (actual)
Study completion: Oct 2011 (actual)
First posted: 12 Mar 2010 (estimated)
Results: Posted 13 Jan 2020

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 safety and efficacy of Levomilnacipran ER relative to placebo in the prevention of depression relapse in patients with major depressive disorder (MDD).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
2	Experimental	Drug: Levomilnacipran ER40, 80 or 120 mg/day Levomilnacipran ER capsules, oral administration, once daily dosing.
1	Placebo comparator	Drug: PlaceboMatching placebo capsules, oral administration, once daily dosing.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Men and women, 18-65 years old
Currently meet the DSM-IV-TR criteria for Major Depressive Disorder
The patient's current depressive episode must be at least 4 weeks in duration

Key exclusion criteria (6 listed)

Women who are pregnant, women who will be breastfeeding during the study, and women with childbearing potential who are not practicing a reliable method of birth control
Patients with a history of meeting DSM-IV-TR criteria for:
Patients who are considered a suicide risk

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
Levomilnacipran ERDrug: Levomilnacipran ER (40, 80 or 120 mg/day) Study drug is to be given orally, in capsule form, once daily.	Drug	2
PlaceboMatching placebo to be given orally, in capsule form, once daily.	Drug	1

Primary outcome

Time to Relapse (Days)
Time frame: 24 Weeks
Number of days until patients meet relapse criteria. Relapse was defined as 1 or more of the following: 1. MADRS total score of at least 22 at 2 consecutive visits 2. Increase of 2 or more points in CGI-I score compared with the CGI-I score at Visit 9 at 2 consecutive visits 3. Premature discontinuation due to insufficient therapeutic response 4. MADRS item 10 score of at least 4

Results and safety

Results posted to the registry on 13 Jan 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	0	0
Levomilnacipran ER	734	494

Primary outcome: Time to Relapse (Days)

Time frame: 24 Weeks. Mean (Standard Deviation). Unit: Days

Measure	Placebo n = 112	Levomilnacipran ER n = 230
Value	NA (NA)	NA (NA)

Population analysed: The double blind Intent-to-treat population consists of 342 randomized participants who received study drug and were evaluated for the Primary Outcome Measure

Adverse events

Time frame: Adverse event data was collection over a 20-month period from March 2010 to November 2011 at 36 study sites in the U.S and Canada.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Open Label Levomilnacipran ER	7 of 734 (1%)	448 of 734 (61%)	0 of 734
Placebo - Double Blind Treatment	4 of 112 (3.6%)	31 of 112 (27.7%)	0 of 112
Levomilnacipran ER - Double Blind Treatment	2 of 233 (0.9%)	68 of 233 (29.2%)	0 of 233

Limitations and caveats (from the sponsor): This was a failed study. The lower than expected rate of relapse in the placebo group compromised the projected power to demonstrate a difference between groups.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Giovanna Forero, MA study director

Forest Laboratories

35 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Levomilnacipran ER in people with Depression and Major Depressive Disorder, run by Forest Laboratories at 35 sites in 2 countries.

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 6 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 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States, Canada. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 13 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Time to Relapse (Days) (time frame: 24 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 NCT01085812.

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 13 Jan 2020.