Major Depressive DisorderPhase 3NCT00969709

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 38 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 fixed doses versus placebo in the treatment of outpatients with major depressive disorder. Read more about this study

Who is it for?: Ages 18 to 65 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: 724 participants
Where: 38 sitesUnited States
Study dates: Sep 2009to May 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 8 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

38 sites in 1 country.

City, postcode or hospital

38 sites in 1 country

United States38 sites

Forest Investigative Site
Baltimore, Maryland, 21285
Forest Investigative Site
Bellevue, Washington, 98007
Forest Investigative Site
Beverly Hills, California, 90210
Forest Investigative Site
Brooklyn, New York, 11235
Forest Investigative Site
Canton, Ohio, 44718
Forest Investigative Site
Cherry Hill, New Jersey, 08002
Forest Investigative Site
Coral Springs, Florida, 33067
Forest Investigative Site
Costa Mesa, California, 92626
Forest Investigative Site
Cromwell, Connecticut, 06416
Forest Investigative Site
Dallas, Texas, 75230
Forest Investigative Site
Dallas, Texas, 75231
Forest Investigative Site
Denver, Colorado, 80239
Forest Investigative Site
Escondido, California, 92025
Forest Investigative Site
Fort Myers, Florida, 33912
Forest Investigative Site
Hallandale, Florida, 33009
Forest Investigative Site
Hoffman Estates, Illinois, 60169
Forest Investigative Site
Jacksonville, Florida, 32216
Forest Investigative Site
Lincoln, Rhode Island, 02865
Forest Investigative Site
Media, Pennsylvania, 19063
Forest Investigative Site
Memphis, Tennessee, 38119
Forest Investigative Site
Mount Kisco, New York, 10549
Forest Investigative Site
New York, New York, 10003
Forest Investigative Site
New York, New York, 10021
Forest Investigative Site
Norristown, Pennsylvania, 19403
Forest Investigative Site
Oceanside, California, 92056
Forest Investigative Site
Orlando, Florida, 32806
Forest Investigative Site
Phoenix, Arizona, 85020
Forest Investigative Site
Portland, Oregon, 97210
Forest Investigative Site
Raleigh, North Carolina, 27607
Forest Investigative Site
Rockville, Maryland, 20852
Forest Investigative Site
San Antonio, Texas, 78229
Forest Investigative Site
Scottsdale, Arizona, 85254
Forest Investigative Site
Seattle, Washington, 98104
Forest Investigative Site
Sherman Oaks, California, 91403
Forest Investigative Site
Staten Island, New York, 10312
Forest Investigative Site
West Palm Beach, Florida, 33407
Forest Investigative Site
Wichita, Kansas, 67206
Forest Investigative Site
Willingboro, New Jersey, 08046

Other trials in United States

About this study

Official title: A Double-blind, Placebo-Controlled, Fixed-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 fixed doses 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, 40 mg, oral administration, in capsule form, once daily for 8 weeks.
Levomilnacipran ERDrug
Levomilnacipran ER, 80 mg, oral administration, in capsule form, once daily for 8 weeks.
Levomilnacipran ERDrug
Levomilnacipran ER, 120 mg, oral administration, in capsule form, once daily for 8 weeks.
PlaceboDrug
Matching placebo capsules, oral administration, once daily for 8 weeks.

Study groups in NCT00969709
Study group	Role	What they receive
1	Experimental	40 mg Levomilnacipran ER capsules, low dose, oral administration, once daily. Receives: Drug: Levomilnacipran ER
2	Experimental	80 mg Levomilnacipran ER capsules, medium dose, oral administration, once daily dosing Receives: Drug: Levomilnacipran ER
3	Experimental	120 mg Levomilnacipran ER capsules, high dose, oral administration, once daily dosing Receives: Drug: Levomilnacipran ER
4	Placebo comparator	Matching placebo capsules, oral administration, once daily. Receives: Drug: Placebo

What is being measured

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

Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
The 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 for all measured symptoms).
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 functional 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 for all measured symptoms)
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.

Sep 2009May 2011

First posted1 Sep 2009 (estimated)
Study startSep 2009
Primary completionMay 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: 724 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00969709
Sponsor's protocol ID: LVM-MD-01
Status last verified: Aug 2013
First submitted: 31 Aug 2009
Last updated: 25 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
Blum SI, Tourkodimitris S, Ruth A. Evaluation of functional health and well-being in patients receiving levomilnacipran ER for the treatment of major depressive disorder. J Affect Disord. 2015 Jan 1;170:230-6. doi: 10.1016/j.jad.2014.09.005. Epub 2014 Sep 10.
PubMed 25259674
Asnis GM, Bose A, Gommoll CP, Chen C, Greenberg WM. Efficacy and safety of levomilnacipran sustained release 40 mg, 80 mg, or 120 mg in major depressive disorder: a phase 3, randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2013 Mar;74(3):242-8. doi: 10.4088/JCP.12m08197.
PubMed 23561229

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 25 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 F2695 SR in Patients With Major Depressive Disorder
ClinicalTrials.gov ID: NCT00969709
Acronym / sponsor ID: LVM-MD-01
Conditions: Major Depressive Disorder
Keywords: Depression, Major Depressive Disorder
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 724 participants (actual)
Lead sponsor: Forest LaboratoriesIndustry (pharma, biotech, devices)
Study start: Sep 2009
Primary completion: May 2011 (actual)
First posted: 1 Sep 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 fixed doses 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: 4

Arm	Type	Receives
1	Experimental	Drug: Levomilnacipran ER40 mg Levomilnacipran ER capsules, low dose, oral administration, once daily.
2	Experimental	Drug: Levomilnacipran ER80 mg Levomilnacipran ER capsules, medium dose, oral administration, once daily dosing
3	Experimental	Drug: Levomilnacipran ER120 mg Levomilnacipran ER capsules, high dose, oral administration, once daily dosing
4	Placebo comparator	Drug: PlaceboMatching placebo capsules, oral administration, once daily.

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 8 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 ERLevomilnacipran ER, 40 mg, oral administration, in capsule form, once daily for 8 weeks.	Drug	1
Levomilnacipran ERLevomilnacipran ER, 80 mg, oral administration, in capsule form, once daily for 8 weeks.	Drug	2
Levomilnacipran ERLevomilnacipran ER, 120 mg, oral administration, in capsule form, once daily for 8 weeks.	Drug	3
PlaceboMatching placebo capsules, oral administration, once daily for 8 weeks.	Drug	4

Primary outcome

Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
Time frame: From Baseline to Week 8
The 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 for all measured symptoms).

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	176	138
Levomilnacipran ER 40 mg	178	130
Levomilnacipran ER 80 mg	179	121
Levomilnacipran ER 120 mg	180	117

Primary outcome: Change in Montgomery-Åsberg 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 = 175	Levomilnacipran ER 40 mg n = 176	Levomilnacipran ER 80 mg n = 177	Levomilnacipran ER 120 mg n = 176
Value	-11.6 (0.97)	-14.8 (0.99)	-15.6 (1.00)	-16.5 (1.02)

Placebo vs Levomilnacipran ER 40 mg: Least squares mean difference: -3.23 (95% CI -5.92 to -0.54), p = 0.0186, Mixed Models Analysis
Placebo vs Levomilnacipran ER 80 mg: Least squares mean difference: -3.99 (95% CI -6.69 to -1.29), p = 0.0038, Mixed Models Analysis
Placebo vs Levomilnacipran ER 120 mg: Least squares mean difference: -4.86 (95% CI -7.59 to -2.12), p = 0.0005, Mixed Models Analysis

Population analysed: A total of 724 patients were randomized to receive double-blind treatment (Randomized Population); 713 patients received at least 1 dose of treatment (Safety Population); and 704 patients received at least 1 dose of treatment and had at least 1 postbaseline MADRS-CR assessment (Intent to Treat \[ITT\] Population).

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data was collected over a 20 month period from September 2009 to June 2011 at 38 study sites.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 176 (0.6%)	66 of 176 (37.5%)	Not reported
Levomilnacipran ER 40 mg	3 of 178 (1.7%)	110 of 178 (61.8%)	Not reported
Levomilnacipran ER 80 mg	2 of 179 (1.1%)	122 of 179 (68.2%)	Not reported
Levomilnacipran ER 120 mg	1 of 180 (0.6%)	112 of 180 (62.2%)	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 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 25259674Blum SI, Tourkodimitris S, Ruth A. Evaluation of functional health and well-being in patients receiving levomilnacipran ER for the treatment of major depressive disorder. J Affect Disord. 2015 Jan 1;170:230-6. doi: 10.1016/j.jad.2014.09.005. Epub 2014 Sep 10.
Derived from this study: PubMed 23561229Asnis GM, Bose A, Gommoll CP, Chen C, Greenberg WM. Efficacy and safety of levomilnacipran sustained release 40 mg, 80 mg, or 120 mg in major depressive disorder: a phase 3, randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2013 Mar;74(3):242-8. doi: 10.4088/JCP.12m08197.

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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.

38 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 38 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 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 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 38 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-Åsberg 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 NCT00969709, 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.