Depressive Disorder, MajorPhase 4NCT02288325
A Multicenter, Relapse Prevention Study With Levomilnacipran Extended Release (ER) in Participants With Major Depressive Disorder
A Phase 4 study testing Levomilnacipran ER in people with Depressive Disorder, Major, run by Forest Laboratories at 47 sites in United States.
Trial summary
This study evaluates the efficacy, safety and tolerability of levomilnacipran extended-release (ER) compared with placebo in the prevention of depression relapse in major depressive disorder (MDD). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Depressive Disorder, Major
- 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
- 644 participants
- Where
- 47 sitesUnited States
- Study dates
- 18 Nov 2014to 16 Sep 2016
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently meet the DMS-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th edition) criteria for Major Depressive Disorder (MDD)
- The participant must have an ongoing major depressive episode of at least 8 weeks and no more than 18 months
- The participant must have at least 3 lifetime episodes of MDD (including the current episode)
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
- Participants who are considered a suicide risk
- History of non-response to 2 or more antidepressants (after adequate treatment)
- Participants who have a history of meeting DMS-5 criteria for manic, hypomanic, or mixed episode, obsessive-compulsive disorder, schizophrenia or other psychotic disorder
- Panic disorder
Trial locations and contacts
47 sites in 1 country.
47 sites in 1 country
United States47 sites
Forest Investigative Site 034
Alpharetta, Georgia, 30005
Forest Investigative Site 048
Beverly Hills, California, 90210
Forest Investigative Site 053
Birmingham, Alabama, 35294
Forest Investigative Site 023
Bradenton, Florida, 34201
Forest Investigative Site 031
Brooklyn, New York, 11235
Forest Investigative Site 026
Brown Deer, Wisconsin, 53223
Forest Investigative Site 036
Cedarhurst, New York, 11516
Forest Investigative Site 058
Charlotte, North Carolina, 28211
Forest Investigative Site 010
Charlottesville, Virginia, 22911
Forest Investigative Site 044
Cherry Hill, New Jersey, 08002
Forest Investigative Site 047
Chino, California, 91710
Forest Investigative Site 028
Costa Mesa, California, 92626
Forest Investigative Site 040
Cromwell, Connecticut, 06475
Forest Investigative Site 054
Dallas, Texas, 75243
Forest Investigative Site 011
Dayton, Ohio, 45417
Forest Investigative Site 050
Dothan, Alabama, 36303
Forest Investigative Site 021
Encino, California, 91316
Forest Investigative Site 018
Fort Myers, Florida, 33912
Forest Investigative Site 059
Houston, Texas, 77090
Forest Investigative Site 001
Jacksonville, Florida, 32256
Forest Investigative Site 008
Jacksonville Beach, Florida, 32250
Forest Investigative Site 057
Kissimmee, Florida, 34741
Forest Investigative Site 052
Lemon Grove, California, 91945
Forest Investigative Site 012
Media, Pennsylvania, 19063
Forest Investigative Site 030
Memphis, Tennessee, 38119
Forest Investigative Site 033
Memphis, Tennessee, 38119
Forest Investigative Site 020
Methuen, Massachusetts, 01844
Forest Investigative Site 013
Mount Kisco, New York, 10549
Forest Investigative Site 014
Murray, Utah, 84123
Forest Investigative Site 003
New York, New York, 10003
Forest Investigative Site 005
New York, New York, 10168
Forest Investigative Site 038
Norwich, Connecticut, 06360
Forest Investigative Site 042
Oceanside, California, 92056
Forest Investigative Site 009
Orlando, Florida, 32801
Forest Investigative Site 039
Phoenix, Arizona, 85032
Forest Investigative Site 046
Portland, Oregon, 97210
Forest Investigative Site 056
Roanoke, Virginia, 24014
Forest Investigative Site 055
Rochester, New York, 14618
Forest Investigative Site 041
Salem, Oregon, 97301
Forest Investigative Site 019
Schaumburg, Illinois, 60194
Forest Investigative Site 016
Sherman Oaks, California, 91403
Forest Investigative Site 037
Sherman Oaks, California, 91403
Forest Investigative Site 043
Simi Valley, California, 93065
Forest Investigative Site 049
Smyrna, Georgia, 30080
Forest Investigative Site 035
Tulsa, Oklahoma, 74104
Forest Investigative Site 051
Watertown, Massachusetts, 02472
Forest Investigative Site 045
West Palm Beach, Florida, 33407
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-Controlled, Relapse-Prevention Study With Levomilnacipran ER in Patients With Major Depressive Disorder
This study evaluates the efficacy, safety and tolerability of levomilnacipran extended-release (ER) compared with placebo in the prevention of depression relapse in major depressive disorder (MDD).
- Conditions
- Depressive Disorder, Major
- Being tested
- Levomilnacipran ER, Placebo
- Keywords
- Fetzima, Relapse-prevention, Placebo-controlled
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levomilnacipran ERDrug
Also called FETZIMA®
Levomilnacipran ER taken orally at 40, 80 or 120 mg once daily.
PlaceboDrug
Dose-matched placebo taken orally once daily.
| Study group | Role | What they receive |
|---|---|---|
| Open-Label FETZIMA® | Experimental | FETZIMA® (levomilnacipran extended release [ER]) taken orally during flexible dose titration up to 40, 80 or 120 mg once daily in 8-week run-in period followed by fixed dose of 40, 80 or 120 mg once daily in 12-week stabilization period. Receives: Drug: Levomilnacipran ER |
| Double-Blind Placebo | Placebo comparator | Dose-matched placebo taken orally once daily for 26 weeks during double-blind treatment period. Receives: Drug: Placebo |
| Double-Blind FETZIMA® | Experimental | FETZIMA® (levomilnacipran ER) taken orally at fixed dose of 40, 80 or 120 mg once daily for 26 weeks during double-blind treatment period. Receives: Drug: Levomilnacipran ER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Relapse During the Double-Blind Treatment Period (DBTP)
Time to relapse for the median was measured in days from randomization date at the start of the DBTP to relapse date during DBTP. Relapse was defined as meeting any 1 or more of the following criteria: 1) Insufficient therapeutic response at any one visit, including a >/= 2 increase in Clinical Global Impressions-Severity (CGI-S) score (range 1 to 7) compared with that obtained at randomization, or risk of suicide as determined by the investigator, or need for hospitalization due to worsening of depression as determined by the investigator, or need for alternative treatment of depressive symptoms as determined by the Investigator; 2) Montgomery-Asberg Depression Rating Scale (MADRS) total score >/= 18 (range 0 to 60) at 2 consecutive visits (second visit within 7 to 14 days after the first visit at which the MADRS total score was ≥ 18). Participant was considered censored at the last visit during DBTP if participant did not meet the relapse criteria during DBTP.
Measured: From the randomization date (Week 20) to the relapse date during the 26-week DBTP (up to Week 46)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2014 (estimated)
- Study start18 Nov 2014
- Primary completion16 Sep 2016
- Study completion16 Sep 2016
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 Depressive Disorder, MajorStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 644 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raffaele Migliore, Study director, Forest Research Institute, Inc., an affiliate of Allergan, plc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02288325
- Sponsor's protocol ID
- LVM-MD-15
- Status last verified
- Sep 2018
- First submitted
- 7 Nov 2014
- Last updated
- 29 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. 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 Levomilnacipran ER in Patients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT02288325
- Acronym / sponsor ID
- LVM-MD-15
- Conditions
- Depressive Disorder, Major
- Keywords
- Fetzima, Relapse-prevention, Placebo-controlled
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 644 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2014 (actual)
- Primary completion
- 16 Sep 2016 (actual)
- Study completion
- 16 Sep 2016 (actual)
- First posted
- 11 Nov 2014 (estimated)
- Results
- Posted 29 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the efficacy, safety and tolerability of levomilnacipran extended-release (ER) compared with placebo in the prevention of depression relapse in 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 |
|---|---|---|
| Open-Label FETZIMA® | Experimental | Drug: Levomilnacipran ERFETZIMA® (levomilnacipran extended release [ER]) taken orally during flexible dose titration up to 40, 80 or 120 mg once daily in 8-week run-in period followed by fixed dose of 40, 80 or 120 mg once daily in 12-week stabilization period. |
| Double-Blind Placebo | Placebo comparator | Drug: PlaceboDose-matched placebo taken orally once daily for 26 weeks during double-blind treatment period. |
| Double-Blind FETZIMA® | Experimental | Drug: Levomilnacipran ERFETZIMA® (levomilnacipran ER) taken orally at fixed dose of 40, 80 or 120 mg once daily for 26 weeks during double-blind treatment period. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Currently meet the DMS-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th edition) criteria for Major Depressive Disorder (MDD)
- The participant must have an ongoing major depressive episode of at least 8 weeks and no more than 18 months
- The participant must have at least 3 lifetime episodes of MDD (including the current episode)
Key exclusion criteria (5 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
- Participants who are considered a suicide risk
- History of non-response to 2 or more antidepressants (after adequate treatment)
- Participants who have a history of meeting DMS-5 criteria for manic, hypomanic, or mixed episode, obsessive-compulsive disorder, schizophrenia or other psychotic disorder
- Panic 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 ERAlso: FETZIMA®Levomilnacipran ER taken orally at 40, 80 or 120 mg once daily. | Drug | Double-Blind FETZIMA®, Open-Label FETZIMA® |
| PlaceboDose-matched placebo taken orally once daily. | Drug | Double-Blind Placebo |
Primary outcome
Time to First Relapse During the Double-Blind Treatment Period (DBTP)
Time frame: From the randomization date (Week 20) to the relapse date during the 26-week DBTP (up to Week 46)
Time to relapse for the median was measured in days from randomization date at the start of the DBTP to relapse date during DBTP. Relapse was defined as meeting any 1 or more of the following criteria: 1) Insufficient therapeutic response at any one visit, including a >/= 2 increase in Clinical Global Impressions-Severity (CGI-S) score (range 1 to 7) compared with that obtained at randomization, or risk of suicide as determined by the investigator, or need for hospitalization due to worsening of depression as determined by the investigator, or need for alternative treatment of depressive symptoms as determined by the Investigator; 2) Montgomery-Asberg Depression Rating Scale (MADRS) total score >/= 18 (range 0 to 60) at 2 consecutive visits (second visit within 7 to 14 days after the first visit at which the MADRS total score was ≥ 18). Participant was considered censored at the last visit during DBTP if participant did not meet the relapse criteria during DBTP.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
- 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.
Raffaele Migliore study director
Forest Research Institute, Inc., an affiliate of Allergan, plc
47 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levomilnacipran ER in people with Depressive Disorder, Major, run by Forest Laboratories at 47 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 5 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 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 2018). 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 First Relapse During the Double-Blind Treatment Period (DBTP) (time frame: From the randomization date (Week 20) to the relapse date during the 26-week DBTP (up to Week 46)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2018.