Major Depressive DisorderPhase 3NCT02431806

Safety and Efficacy of Levomilnacipran ER in Adolescent Participants With Major Depressive Disorder

A Phase 3 study testing Levomilnacipran and Fluoxetine in people with Major Depressive Disorder, run by Forest Laboratories at 49 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 12 to 17 years
Conditions the study is for: Major Depressive Disorder
What is being tested?: Levomilnacipran and Fluoxetine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 552 participants
Where: 49 sitesin 2 countries
Study dates: 23 Jun 2015to 19 Aug 2019
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 12 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Male or female outpatients;12-17 years of age
Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for MDD, confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children--Present and Lifetime (K-SADS-PL)
Score ≥ 40 on the Children's Depression Rating Scale-Revised (CDRS-R) at Visits 1 and 2
Clinical Global Impressions-Severity (CGI-S) score ≥ 4 at Visits 1 and 2
Reliable caregiver
Physical examination, vital signs, clinical laboratory tests, and electrocardiogram (ECG) normal or not clinically significant

Show all 22Show fewer

Key Psychiatric Exclusion Criteria:
DSM-IV-TR-based diagnosis of an axis I disorder other than MDD that is the primary focus of treatment
Mental retardation or amnestic or other cognitive disorders
Significant suicide risk:
Suicide attempt within the past year OR
Investigator judgment (based on psychiatric interview and Columbia-Suicide Severity Rating Scale (C-SSRS))
Key Treatment-Related Exclusion Criteria:
Allergy, intolerance, or hypersensitivity to levomilnacipran, milnacipran, fluoxetine, or any other selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI)
Use of prohibited concomitant medication that cannot be discontinued
Other Key Medical Exclusion Criteria:
Any current medical condition that might interfere with the conduct of the study, confound the interpretation of study results, or affect participants safety
Liver enzyme tests aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2X the upper limit of normal (ULN)
Clinically significant cardiovascular disorders
Seizure disorder or risk of seizure
Drug or alcohol abuse or dependence (within the past year)
Positive urine drug screen or blood alcohol

Who cannot join

None listed.

Trial locations and contacts

49 sites in 2 countries.

Country

City, postcode or hospital

49 sites in 2 countries

United States48 sites

Advanced Research Center, Inc.
Anaheim, California, 92801
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
Kentucky Pediatric Research
Bardstown, Kentucky, 40004
Northwest Clinical Research Center
Bellevue, Washington, 98007
Florida Clinical Research Center; LLC
Bradenton, Florida, 34201
UVA Child and Family Psychiatry Clinic
Charlottesville, Virginia, 22903
MCB Clinical Research Center
Colorado Springs, Colorado, 80910
ProScience Research Group
Culver City, California, 90230
Midwest Clinical Research Center
Dayton, Ohio, 45417
Harmonex, Inc
Dothan, Alabama, 36303
Eastside Therapeutic Resource dba Core Clinical
Everett, Washington, 98201
Coastal Clinical Research Specialists
Fernandina Beach, Florida, 32034
Gulfcoast Clinical Research Center
Fort Myers, Florida, 33912
Research in Miami Inc
Hialeah, Florida, 33013
Advanced Research Institute of Miami
Homestead, Florida, 33030
UTHSC-Houston
Houston, Texas, 77054
Bay Area Clinical Services dba Earle Research
Houston, Texas, 77058
Red Oak Psychiatry Associates
Houston, Texas, 77090
Sun Valley Research Center
Imperial, California, 92251
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256
Kolade Research Institute
Las Vegas, Nevada, 89102
Innovative Clinical Research, Inc.
Lauderhill, Florida, 33319
Alivation Research
Lincoln, Nebraska, 68526
Alliance for Research
Long Beach, California, 90807
Professional Psychiatric Services
Mason, Ohio, 45040
Sandeep Gaonkar, MD
Naperville, Illinois, 60563
Healthy Perspectives - Innovative Mental Health Services. PLLC
Nashua, New Hampshire, 03060
Manhattan Behavioral Medicine
New York, New York, 10036
IPS Research Company
Oklahoma City, Oklahoma, 73106
Sooner Clinical Research
Oklahoma City, Oklahoma, 73112
Cutting Edge Research Group
Oklahoma City, Oklahoma, 73116
Paradigm Research Professionals
Oklahoma City, Oklahoma, 73118
Medical Research Group of Central Florida
Orange City, Florida, 32763
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801
NeuroMedical Institute
Panama, Illinois, 32405
Asclepes Research Centers
Panorama City, California, 91402
Princeton Medical Institute
Princeton, New Jersey, 08540
Carilion Medical Center
Roanoke, Virginia, 24014
Oregon Center for Clinical Investigations, Inc.
Salem, Oregon, 97301
Syrentis Clinical Research
Santa Ana, California, 97025
Institute for Behavioral Medicine
Smyrna, Georgia, 30080-2620
Clinical Research Institute
Stockbridge, Georgia, 30281
University of South Florida Board of Trustee
Tampa, Florida, 33613
Family Psychiatry of The Woodlands
The Woodlands, Texas, 77381
University of Arizona Department of Psychiatry
Tucson, Arizona, 85724
Tulsa Clinical Research, LLC
Tulsa, Oklahoma, 74104
Pacific Clinical Research Medical Group
Upland, California, 91786
Adams Clinical Trials, LLC
Watertown, Massachusetts, 02472

Other trials in United States

Puerto Rico1 site

INSPIRA Clinical Research
San Juan, 00918

Other trials in Puerto Rico

About this study

Official title: A Double-blind, Placebo- and Active-Controlled Evaluation of the Safety and Efficacy of Levomilnacipran ER in Adolescent Patients With Major Depressive Disorder

The purpose of this study is to evaluate the efficacy, safety, and tolerability of levomilnacipran ER relative to placebo in adolescent outpatients (12-17 years) with Major Depressive Disorder (MDD). In addition, the study is designed to obtain pharmacokinetics (PK) data to guide dose selection for future pediatric studies of levomilnacipran.

Read the detailed description

Study LVM-MD-11 is a randomized, double-blind, placebo- and active-controlled, parallel group, fixed-dose study in adolescent patients, ages 12-17 years. The study will be approximately 10 weeks in duration:

1-week screening/washout period
8-week double-blind treatment period
1-week double-blind down-taper period

Participants who meet the eligibility criteria at Visit 2 (Baseline) will be randomized to 1 of 4 treatment groups: placebo, levomilnacipran 40 mg/day, levomilnacipran 80 mg/day, or fluoxetine 20 mg/day.

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

PlaceboDrug
Matched over-encapsulated placebo capsules administered orally on Day 1 to Week 8.
LevomilnacipranDrug
Also called Fetzima
Over-encapsulated levomilnacipran ER capsules administered orally on Day 1 to Week 8.
FluoxetineDrug
Also called Prozac
Over-encapsulated fluoxetine tablets administered orally on Day 1 to Week 8.

Study groups in NCT02431806
Study group	Role	What they receive
Placebo	Placebo comparator	Participants received 2 dose matched over-encapsulated placebo capsules, once daily, orally during the Double-blind Treatment Period up to 8 weeks followed by a 1 week Taper-down Period if applicable as determined by the investigator. Receives: Drug: Placebo
Levomilnacipran 40 mg	Experimental	Participants received over-encapsulated levomilnacipran extended release (ER) 40 mg/day capsules orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Days 3-7 and 40 mg/day on Week 2 through Week 8 during the Double-Blind Treatment Period, followed by a 1-week Double-Blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind. Receives: Drug: Levomilnacipran
Levomilnacipran 80 mg	Experimental	Participants received over-encapsulated levomilnacipran ER two 40 mg/day capsules (80 mg/day) orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Day 3-4, 40 mg/day on Day 5-7 and 80 mg/day on Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule the first week and during the taper-down period to maintain the blind. Receives: Drug: Levomilnacipran
Fluoxetine 20 mg	Active comparator	Participants received over-encapsulated fluoxetine 20 mg/day tablets orally starting at a dose of 10 mg/day in Week 1 and 20 mg/day in Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind. Receives: Drug: Fluoxetine

What is being measured

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

Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score
CDRS-R is a 17-item scale measuring presence and severity of symptoms commonly associated with childhood depression and is scored on a 1-to-5- or 1-to-7-point scale. Rating of 1 indicates normal function. The CDRS-R total score ranges from 17 to 113; higher score indicates more severe depression. A negative change from Baseline indicates improvement. Mixed Model for Repeated Measures (MMRM) was used for analysis.
Measured: Baseline (Week 0) to Week 8

Secondary outcomes (1)

Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale
The CGI-S is a clinician-rated scale used to rate the severity of the participants current state of mental illness compared with MDD population. The participant was rated on a scale from 1 to 7, where 1= Very much improved; 2= Much improved; 3= Minimally improved; 4= No change; 5= Minimally worse; 6= Much worse; 7= Very much worse. Higher score indicates worsening of mental illness. A negative change from Baseline indicates improvement. MMRM was used for analysis.
Measured: Baseline (Week 0) to Week 8

Timeline

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

23 Jun 201519 Aug 2019

First posted1 May 2015 (estimated)
Study start23 Jun 2015
Primary completion19 Aug 2019
Study completion19 Aug 2019

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 (1)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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 552 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02431806
Sponsor's protocol ID: LVM-MD-11
Status last verified: Aug 2020
First submitted: 28 Apr 2015
Last updated: 7 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Radecki DT, Robieson WZ, Gopalkrishnan M, Greenberg E, Aziz M. Safety and Efficacy of Levomilnacipran Extended Release in Pediatric Patients Aged 7-17 Years with Major Depressive Disorder: Results of Two Phase 3, Randomized, Double-Blind Studies. J Child Adolesc Psychopharmacol. 2024 Jun;34(5):241-250. doi: 10.1089/cap.2023.0080. Epub 2024 May 3.
PubMed 38700708

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 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Placebo- and Active-Controlled Evaluation of the Safety and Efficacy of Levomilnacipran ER in Adolescent Patients With Major Depressive Disorder
ClinicalTrials.gov ID: NCT02431806
Acronym / sponsor ID: LVM-MD-11
Conditions: Major Depressive Disorder
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 552 participants (actual)
Lead sponsor: Forest LaboratoriesIndustry (pharma, biotech, devices)
Study start: 23 Jun 2015 (actual)
Primary completion: 19 Aug 2019 (actual)
Study completion: 19 Aug 2019 (actual)
First posted: 1 May 2015 (estimated)
Results: Posted 7 Sep 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

1-week screening/washout period
8-week double-blind treatment period
1-week double-blind down-taper period

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboParticipants received 2 dose matched over-encapsulated placebo capsules, once daily, orally during the Double-blind Treatment Period up to 8 weeks followed by a 1 week Taper-down Period if applicable as determined by the investigator.
Levomilnacipran 40 mg	Experimental	Drug: LevomilnacipranParticipants received over-encapsulated levomilnacipran extended release (ER) 40 mg/day capsules orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Days 3-7 and 40 mg/day on Week 2 through Week 8 during the Double-Blind Treatment Period, followed by a 1-week Double-Blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.
Levomilnacipran 80 mg	Experimental	Drug: LevomilnacipranParticipants received over-encapsulated levomilnacipran ER two 40 mg/day capsules (80 mg/day) orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Day 3-4, 40 mg/day on Day 5-7 and 80 mg/day on Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule the first week and during the taper-down period to maintain the blind.
Fluoxetine 20 mg	Active comparator	Drug: FluoxetineParticipants received over-encapsulated fluoxetine 20 mg/day tablets orally starting at a dose of 10 mg/day in Week 1 and 20 mg/day in Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.

Who may qualify

Ages: 12 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (22 listed)

Male or female outpatients;12-17 years of age
Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for MDD, confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children--Present and Lifetime (K-SADS-PL)
Score ≥ 40 on the Children's Depression Rating Scale-Revised (CDRS-R) at Visits 1 and 2
Clinical Global Impressions-Severity (CGI-S) score ≥ 4 at Visits 1 and 2
Reliable caregiver

Key exclusion criteria (0 listed)

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
PlaceboMatched over-encapsulated placebo capsules administered orally on Day 1 to Week 8.	Drug	Placebo
LevomilnacipranAlso: FetzimaOver-encapsulated levomilnacipran ER capsules administered orally on Day 1 to Week 8.	Drug	Levomilnacipran 40 mg, Levomilnacipran 80 mg
FluoxetineAlso: ProzacOver-encapsulated fluoxetine tablets administered orally on Day 1 to Week 8.	Drug	Fluoxetine 20 mg

Primary outcome

Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score
Time frame: Baseline (Week 0) to Week 8
CDRS-R is a 17-item scale measuring presence and severity of symptoms commonly associated with childhood depression and is scored on a 1-to-5- or 1-to-7-point scale. Rating of 1 indicates normal function. The CDRS-R total score ranges from 17 to 113; higher score indicates more severe depression. A negative change from Baseline indicates improvement. Mixed Model for Repeated Measures (MMRM) was used for analysis.

1 secondary outcome

Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale
Time frame: Baseline (Week 0) to Week 8

Results and safety

Results posted to the registry on 7 Sep 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	142	117
Levomilnacipran 40 mg/Day	136	115
Levomilnacipran 80 mg/Day	139	107
Fluoxetine 20 mg/Day	135	109

Primary outcome: Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score

Time frame: Baseline (Week 0) to Week 8. Least squares mean (Standard Error). Unit: score on a scale

Measure	Placebo n = 118	Levomilnacipran 40 mg/Day n = 115	Levomilnacipran 80 mg/Day n = 110	Fluoxetine 20 mg/Day n = 112
Value	-22.90 (1.09)	-23.28 (1.11)	-22.64 (1.12)	-24.37 (1.12)

Placebo vs Levomilnacipran 40 mg/Day: Least Squares (LS) Mean Difference: -0.38 (95% CI -3.41 to 2.64), p = 0.8035, Mixed Model Repeated Measures (MMRM)
Placebo vs Levomilnacipran 80 mg/Day: LS Mean Difference: 0.26 (95% CI -2.80 to 3.31), p = 0.8681, MMRM
Placebo vs Fluoxetine 20 mg/Day: LS Mean: -1.47 (95% CI -4.52 to 1.58), p = 0.3439, MMRM

Population analysed: ITT Population included all participants in the Safety Population who had the baseline and at least 1 postbaseline assessment of the CDRS-R total score. Overall number of participants analyzed is the number of participants with data available for analyses.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: First dose of study treatment to end of study follow-up (Up to 10 Weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 141 (0%)	33 of 141 (23.4%)	0 of 141
Levomilnacipran 40 mg/Day	2 of 134 (1.5%)	54 of 134 (40.3%)	0 of 134
Levomilnacipran 80 mg/Day	0 of 138 (0%)	63 of 138 (45.7%)	0 of 138
Fluoxetine 20 mg/Day	4 of 134 (3%)	41 of 134 (30.6%)	0 of 134

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38700708Radecki DT, Robieson WZ, Gopalkrishnan M, Greenberg E, Aziz M. Safety and Efficacy of Levomilnacipran Extended Release in Pediatric Patients Aged 7-17 Years with Major Depressive Disorder: Results of Two Phase 3, Randomized, Double-Blind Studies. J Child Adolesc Psychopharmacol. 2024 Jun;34(5):241-250. doi: 10.1089/cap.2023.0080. Epub 2024 May 3.
Individual participant dataSharing planned: Undecided

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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.

Daniel Radecki study director

Forest Research Institute, Inc., an affiliate of Allergan, plc

49 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 and Fluoxetine in people with Major Depressive Disorder, run by Forest Laboratories at 49 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 22 inclusion and 0 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 7 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United States, Puerto Rico. 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 7 Sep 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?

Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score (time frame: Baseline (Week 0) 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 NCT02431806, which also lists 1 linked publication.

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 7 Sep 2020.