Major Depressive DisorderPhase 3NCT01034462

Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder

A Phase 3 study testing Levomilnacipran ER in people with Major Depressive Disorder, run by Forest Laboratories at 23 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 efficacy, safety, and tolerability of Levomilnacipran ER versus placebo in the treatment of outpatients 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?: Levomilnacipran ER
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 442 participants
Where: 23 sitesUnited States
Study dates: Dec 2009to Dec 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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Men and women, 18-80 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: a. any manic or hypomanic episode; b. schizophrenia or any other psychotic disorder; c. obsessive-compulsive disorder.
Patients who are considered a suicide risk

Trial locations and contacts

23 sites in 1 country.

City, postcode or hospital

23 sites in 1 country

United States23 sites

Forest Investigative Site 054
Allentown, Pennsylvania, 18104
Forest Investigative Site 070
Atlanta, Georgia, 30328
Forest Investigative Site 057
Boca Raton, Florida, 33431
Forest Investigative Site 060
Boca Raton, Florida, 33432
Forest Investigative Site 051
Brooklyn, New York, 11214
Forest Investigative Site 072
Chicago, Illinois, 60634
Forest Investigative Site 055
Dothan, Alabama, 36305
Forest Investigative Site 064
Gainesville, Florida, 32607
Forest Investigative Site 065
Highlands Ranch, Colorado, 80130
Forest Investigative Site 063
Indianapolis, Indiana, 46260
Forest Investigative Site 050
Oak Brook, Illinois, 60523
Forest Investigative Site 053
Ocala, Florida, 34471
Forest Investigative Site 056
Oklahoma City, Oklahoma, 73112
Forest Investigative Site 067
Oklahoma City, Oklahoma, 73112
Forest Investigative Site 061
Orlando, Florida, 32806
Forest Investigative Site 071
Prairie Village, Kansas, 66206
Forest Investigative Site 058
Salem, Oregon, 97301
Forest Investigative Site 062
San Antonio, Texas, 78229
Forest Investigative Site 052
Shreveport, Louisiana, 71104
Forest Investigative Site 066
Smyrna, Georgia, 30080
Forest Investigative Site 069
Spokane, Washington, 99204
Forest Investigative Site 068
Virginia Beach, Virginia, 23452
Forest Investigative Site 059
Winter Park, Florida, 32789

Other trials in United States

About this study

Official title: A Double-blind, Placebo-Controlled, Flexible-Dose Study of F2695 SR in Patients With Major Depressive Disorder

The purpose of this study is to evaluate the efficacy, safety, and tolerability of Levomilnacipran ER versus placebo in the treatment of outpatients with major depressive disorder

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
Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing. 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 NCT01034462
Study group	Role	What they receive
1	Experimental	Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing. Receives: Drug: Levomilnacipran ER
2	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.

Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
MADRS was used to assess depressive symptomatology during the past week. Patients are rated 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 of the 10 items are scored on a 7-point scale. A score of 0 indicates the absence of symptoms,and a score of 6 indicates symptoms of maximum severity. The total MADRS score for this measure ranges from 0 (absence of symptoms) to 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.

Dec 2009Dec 2011

First posted17 Dec 2009 (estimated)
Study startDec 2009
Primary completionDec 2011
Study completionDec 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.
Publications (3)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: 442 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01034462
Sponsor's protocol ID: LVM-MD-03
Status last verified: Aug 2013
First submitted: 16 Dec 2009
Last updated: 25 Oct 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Wesnes KA, Gommoll C, Chen C, Sambunaris A, McIntyre RS, Harvey PD. Effects of levomilnacipran extended-release on major depressive disorder patients with cognitive impairments: post-hoc analysis of a phase III study. Int Clin Psychopharmacol. 2017 Mar;32(2):72-79. doi: 10.1097/YIC.0000000000000157.
PubMed 27861191
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
Sambunaris A, Bose A, Gommoll CP, Chen C, Greenberg WM, Sheehan DV. A phase III, double-blind, placebo-controlled, flexible-dose study of levomilnacipran extended-release in patients with major depressive disorder. J Clin Psychopharmacol. 2014 Feb;34(1):47-56. doi: 10.1097/JCP.0000000000000060.
PubMed 24172209

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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Study at a glance

From the registry record, last updated by the sponsor on 25 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Placebo-Controlled, Flexible-Dose Study of F2695 SR in Patients With Major Depressive Disorder
ClinicalTrials.gov ID: NCT01034462
Acronym / sponsor ID: LVM-MD-03
Conditions: Major Depressive Disorder
Keywords: Depression, Major Depressive Disorder
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 442 participants (actual)
Lead sponsor: Forest LaboratoriesIndustry (pharma, biotech, devices)
Study start: Dec 2009
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 17 Dec 2009 (estimated)
Results: Posted 25 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 versus placebo in the treatment of outpatients with major depressive disorder

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
1	Experimental	Drug: Levomilnacipran ERLevomilnacipran ER capsules, flexible dose, oral administration, once daily dosing.
2	Placebo comparator	Drug: PlaceboMatching placebo capsules, oral administration, once daily 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)

Men and women, 18-80 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 (3 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: a. any manic or hypomanic episode; b. schizophrenia or any other psychotic disorder; c. obsessive-compulsive disorder.
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 ERLevomilnacipran ER capsules, flexible dose, oral administration, once daily dosing. Study drug is to be given orally, in capsule form, once daily, for 8 weeks	Drug	1
PlaceboMatching placebo to be given orally, in capsule form, once daily, for 8 weeks.	Drug	2

Primary outcome

Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Time frame: From Baseline to Week 8
MADRS was used to assess depressive symptomatology during the past week. Patients are rated 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 of the 10 items are scored on a 7-point scale. A score of 0 indicates the absence of symptoms,and a score of 6 indicates symptoms of maximum severity. The total MADRS score for this measure ranges from 0 (absence of symptoms) to 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 25 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	217	172
Levomilnacipran ER	217	163

Primary outcome: Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

Time frame: From Baseline to Week 8. Least squares mean (Standard Error). Unit: units on a scale

Measure	Placebo n = 214	Levomilnacipran ER n = 215
Value	-12.2 (0.78)	-15.3 (0.79)

Placebo: Least squares mean difference: -3.095 (95% CI -5.256 to -0.935), p = 0.0051, Mixed Models Analysis

Population analysed: The Safety Population consisted of 434 randomized patients who took at least 1 dose of double-blind investigational product. The Intent-to-Treat (ITT) Population consisted 429 patients in the Safety Population who had at least 1 postbaseline assessment of the MADRS total score.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data was collection over a 25-month period from December 2009 to January 2012 at 23 study sites in the U.S.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	3 of 217 (1.4%)	79 of 217 (36.4%)	Not reported
Levomilnacipran ER	4 of 217 (1.8%)	151 of 217 (69.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27861191Wesnes KA, Gommoll C, Chen C, Sambunaris A, McIntyre RS, Harvey PD. Effects of levomilnacipran extended-release on major depressive disorder patients with cognitive impairments: post-hoc analysis of a phase III study. Int Clin Psychopharmacol. 2017 Mar;32(2):72-79. doi: 10.1097/YIC.0000000000000157.
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 24172209Sambunaris A, Bose A, Gommoll CP, Chen C, Greenberg WM, Sheehan DV. A phase III, double-blind, placebo-controlled, flexible-dose study of levomilnacipran extended-release in patients with major depressive disorder. J Clin Psychopharmacol. 2014 Feb;34(1):47-56. doi: 10.1097/JCP.0000000000000060.

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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 Inc.

23 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 Levomilnacipran ER in people with Major Depressive Disorder, run by Forest Laboratories at 23 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 25 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 23 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. 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 25 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 (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 NCT01034462, which also lists 3 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 25 Oct 2013.