Major Depressive DisorderPhase 3NCT01377194

Safety and Efficacy of Levomilnacipran ER (Levomilnacipran SR) in Major Depressive Disorder

A Phase 3 study testing Levomilnacipran ER in people with Major Depressive Disorder, run by Forest Laboratories at 51 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 efficacy, safety, and tolerability of Levomilnacipran ER compared to placebo in patients with Major Depressive Disorder (MDD). Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: 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: 568 participants
Where: 51 sitesin 2 countries
Study dates: Jun 2011to Mar 2012
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Men and women, 18-75 years old
Currently meet the DSM-IV-TR criteria for Major Depressive Disorder
The patient's current depressive episode must be at least 6 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 who are considered a suicide risk
Patients with a history of meeting DSM-IV-TR criteria for
a. any manic or hypomanic episode
b. schizophrenia or any other psychotic disorder
c. obsessive-compulsive disorder.

Trial locations and contacts

51 sites in 2 countries.

Country

City, postcode or hospital

51 sites in 2 countries

United States47 sites

Forest Investigative Site 011
Allentown, Pennsylvania, 18104
Forest Investigative Site 046
Atlanta, Georgia, 30328
Forest Investigative Site 022
Bellevue, Washington, 98007
Forest Investigative Site 037
Beverly Hills, California, 90210
Forest Investigative Site 039
Birmingham, Alabama, 35216
Forest Investigative Site 052
Bridgeville, Pennsylvania, 15017
Forest Investigative Site 004
Brooklyn, New York, 11214
Forest Investigative Site 044
Cherry Hill, New Jersey, 08002
Forest Investigative Site 041
Chicago, Illinois, 60634
Forest Investigative Site 054
Chicago, Illinois, 60640
Forest Investigative Site 021
Coral Springs, Florida, 33067
Forest Investigative Site 034
Cromwell, Connecticut, 06416
Forest Investigative Site 009
Dallas, Texas, 75231
Forest Investigative Site 010
Dayton, Ohio, 45417
Forest Investigative Site 012
Encino, California, 91316
Forest Investigative Site 043
Fort Myers, Florida, 33912
Forest Investigative Site 018
Gainesville, Florida, 32607
Forest Investigative Site 060
Hallandale, Florida, 33009
Forest Investigative Site 049
Haverhill, Massachusetts, 01830
Forest Investigative Site 026
Hoffman Estates, Illinois, 60169
Forest Investigative Site 045
Indianapolis, Indiana, 46260
Forest Investigative Site 020
Jacksonville, Florida, 32216
Forest Investigative Site 059
Lincoln, Rhode Island, 02865
Forest Investigative Site 029
Memphis, Tennessee, 38119
Forest Investigative Site 002
Mount Kisco, New York, 10549
Forest Investigative Site 016
New York, New York, 10003
Forest Investigative Site 051
New York, New York, 10021
Forest Investigative Site 038
Newport Beach, California, 92660
Forest Investigative Site 005
Ocala, Florida, 34471
Forest Investigative Site 024
Oceanside, California, 92056
Forest Investigative Site 048
Oklahoma City, Oklahoma, 73112
Forest Investigative Site 042
Orangeburg, New York, 10962
Forest Investigative Site 014
Orlando, Florida, 32806
Forest Investigative Site 028
Orlando, Florida, 32806
Forest Investigative Site 027
Philadelphia, Pennsylvania, 19107
Forest Investigative Site 053
Portland, Oregon, 97210
Forest Investigative Site 056
Prairie Village, Kansas, 66206
Forest Investigative Site 061
Raleigh, North Carolina, 27607
Forest Investigative Site 001
Redlands, California, 92374
Forest Investigative Site 017
Salem, Oregon, 97301
Forest Investigative Site 007
San Antonio, Texas, 78229
Forest Investigative Site 035
San Antonio, Texas, 78229
Forest Investigative Site 031
San Diego, California, 92108
Forest Investigative Site 055
Seattle, Washington, 98104
Forest Investigative Site 050
Sherman Oaks, California, 91403
Forest Investigative Site 057
Spokane, Washington, 99204
Forest Investigative Site 023
Willingboro, New Jersey, 08046

Other trials in United States

Canada4 sites

Forest Investigative Site 006
Chatham, Ontario, N7M 1B7
Forest Investigative Site 025
Kelowna, British Columbia, V1Y 1Z9
Forest Investigative Site 003
Ottawa, Ontario, K1G 4G3
Forest Investigative Site 036
Sydney, Nova Scotia, B1S 2EB

Other trials in Canada

About this study

Official title: A Double-blind, Placebo-Controlled, Fixed-Dose Study of Levomilnacipran SR in Patients With Major Depressive Disorder

The purpose of this study is to evaluate the efficacy, safety, and tolerability of Levomilnacipran ER compared to placebo in patients with Major Depressive Disorder (MDD).

Conditions: Major Depressive Disorder
Being tested: Levomilnacipran ER, Placebo
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.

Levomilnacipran ERDrug
Drug: Levomilnacipran ER 40mg/day Study drug is to be given orally, in capsule form, once daily, for 8 weeks
Levomilnacipran ERDrug
Drug: Levomilnacipran ER 80mg/day Study drug is to be given orally, in capsule form, once daily, for 8 weeks
PlaceboDrug
Matching placebo to be given orally, in capsule form, once daily, for 8 weeks.

Study groups in NCT01377194
Study group	Role	What they receive
1	Experimental	40mg Levomilnacipran ER Receives: Drug: Levomilnacipran ER
2	Experimental	80mg of Levomilnacipran ER Receives: Drug: Levomilnacipran ER
3	Placebo comparator	Placebo Receives: Drug: Placebo

What is being measured

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

Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score - Mixed-effects Model for Repeated Measures (MMRM) Analysis.
The Montgomery-Asberg Depression Rating Scale (MADRS) rates patients on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item was scored on a 7-point scale. A score of 0 indicated the absence of symptoms, and a score of 6 indicated symptoms of maximum severity. The minimum overall score possible was 0 (absence of symptoms), with a maximum overall score of 60 (maximum severity).
Measured: From Baseline to Week 8

Secondary outcomes (1)

Change in Sheehan Disability Scale (SDS) Total Score
The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe)
Measured: From Baseline to Week 8

Timeline

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

Jun 2011Mar 2012

First posted21 Jun 2011 (estimated)
Study startJun 2011
Primary completionMar 2012
Study completionMar 2012

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.
Publications (2)Papers the sponsor has linked to this study.
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: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 568 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01377194
Sponsor's protocol ID: LVM-MD-10
Status last verified: Aug 2013
First submitted: 10 Jun 2011
Last updated: 29 Oct 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Cutler AJ, Gommoll CP, Chen C, Greenberg WM, Ruth A. Levomilnacipran Extended-Release Treatment in Patients With Major Depressive Disorder: Improvements in Functional Impairment Categories. Prim Care Companion CNS Disord. 2015 Jun 11;17(3):10.4088/PCC.14m01753. doi: 10.4088/PCC.14m01753. eCollection 2015.
PubMed 26644957
Bakish D, Bose A, Gommoll C, Chen C, Nunez R, Greenberg WM, Liebowitz M, Khan A. Levomilnacipran ER 40 mg and 80 mg in patients with major depressive disorder: a phase III, randomized, double-blind, fixed-dose, placebo-controlled study. J Psychiatry Neurosci. 2014 Jan;39(1):40-9. doi: 10.1503/jpn.130040.
PubMed 24144196

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 29 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Placebo-Controlled, Fixed-Dose Study of Levomilnacipran SR in Patients With Major Depressive Disorder
ClinicalTrials.gov ID: NCT01377194
Acronym / sponsor ID: LVM-MD-10
Conditions: Major Depressive Disorder
Keywords: Depression, Major Depressive Disorder
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 568 participants (actual)
Lead sponsor: Forest LaboratoriesIndustry (pharma, biotech, devices)
Study start: Jun 2011
Primary completion: Mar 2012 (actual)
Study completion: Mar 2012 (actual)
First posted: 21 Jun 2011 (estimated)
Results: Posted 29 Oct 2013

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 efficacy, safety, and tolerability of Levomilnacipran ER compared to placebo in patients with Major Depressive Disorder (MDD).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
1	Experimental	Drug: Levomilnacipran ER40mg Levomilnacipran ER
2	Experimental	Drug: Levomilnacipran ER80mg of Levomilnacipran ER
3	Placebo comparator	Drug: PlaceboPlacebo

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Men and women, 18-75 years old
Currently meet the DSM-IV-TR criteria for Major Depressive Disorder
The patient's current depressive episode must be at least 6 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 who are considered a suicide risk
Patients with a history of meeting DSM-IV-TR criteria for
a. any manic or hypomanic episode
b. schizophrenia or any other psychotic disorder

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 40mg/day Study drug is to be given orally, in capsule form, once daily, for 8 weeks	Drug	1
Levomilnacipran ERDrug: Levomilnacipran ER 80mg/day Study drug is to be given orally, in capsule form, once daily, for 8 weeks	Drug	2
PlaceboMatching placebo to be given orally, in capsule form, once daily, for 8 weeks.	Drug	3

Primary outcome

Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score - Mixed-effects Model for Repeated Measures (MMRM) Analysis.
Time frame: From Baseline to Week 8
The Montgomery-Asberg Depression Rating Scale (MADRS) rates patients on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item was scored on a 7-point scale. A score of 0 indicated the absence of symptoms, and a score of 6 indicated symptoms of maximum severity. The minimum overall score possible was 0 (absence of symptoms), with a maximum overall score of 60 (maximum severity).

1 secondary outcome

Change in Sheehan Disability Scale (SDS) Total Score
Time frame: From Baseline to Week 8

Results and safety

Results posted to the registry on 29 Oct 2013, 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	186	154
Levomilnacipran ER 40 mg	188	145
Levomilnacipran ER 80 mg	188	142

Primary outcome: Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score - Mixed-effects Model for Repeated Measures (MMRM) Analysis.

Time frame: From Baseline to Week 8. Mean (Standard Deviation). Unit: Units on a scale

Measure	Placebo n = 185	Levomilnacipran ER 40 mg n = 185	Levomilnacipran ER 80 mg n = 187
Value	-11.3 (0.77)	-14.6 (0.79)	-14.4 (0.79)

Placebo vs Levomilnacipran ER 40 mg: Least squares mean difference: -3.303 (95% CI -5.457 to -1.148), p = 0.0027, mixed-model for repeated measures
Placebo vs Levomilnacipran ER 80 mg: Least squares mean difference: -3.141 (95% CI -5.293 to -0.988), p = 0.0043, mixed-model for repeated measures

Population analysed: Of the 568 patients randomized to receive double-blind treatment, 562 patients received at least 1 dose of treatment and were included in the Safety Population, and 557 patients received at least 1 dose of treatment and had at least 1 postbaseline MADRS assessment and were included in the ITT Population.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data was collected over a 10 month period from June 2011 to March 2012.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 186 (0.5%)	58 of 186 (31.2%)	Not reported
Levomilnacipran ER 40 mg	3 of 188 (1.6%)	90 of 188 (47.9%)	Not reported
Levomilnacipran 80 mg	0 of 188 (0%)	110 of 188 (58.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26644957Cutler AJ, Gommoll CP, Chen C, Greenberg WM, Ruth A. Levomilnacipran Extended-Release Treatment in Patients With Major Depressive Disorder: Improvements in Functional Impairment Categories. Prim Care Companion CNS Disord. 2015 Jun 11;17(3):10.4088/PCC.14m01753. doi: 10.4088/PCC.14m01753. eCollection 2015.
Derived from this study: PubMed 24144196Bakish D, Bose A, Gommoll C, Chen C, Nunez R, Greenberg WM, Liebowitz M, Khan A. Levomilnacipran ER 40 mg and 80 mg in patients with major depressive disorder: a phase III, randomized, double-blind, fixed-dose, placebo-controlled study. J Psychiatry Neurosci. 2014 Jan;39(1):40-9. doi: 10.1503/jpn.130040.

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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.

Carl Gommoll, MS study director

Forest Research Institute, a subsidiary of Forest Laboratories

51 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 Major Depressive Disorder, run by Forest Laboratories at 51 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 29 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 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 29 Oct 2013). 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?

Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score - Mixed-effects Model for Repeated Measures (MMRM) Analysis. (time frame: From Baseline to Week 8). 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 NCT01377194, which also lists 2 linked publications.

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 29 Oct 2013.