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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Matched over-encapsulated placebo capsules administered orally on Day 1 to Week 8. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Week 0) to Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Key Inclusion Criteria:
Key Psychiatric Exclusion Criteria:
Key Treatment-Related Exclusion Criteria:
Other Key Medical Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Radecki | Forest Research Institute, Inc., an affiliate of Allergan, plc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harmonex, Inc | Dothan | Alabama | 36303 | United States | ||
| University of Arizona Department of Psychiatry |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38700708 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | 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. |
| FG001 | Levomilnacipran 40 mg/Day |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-blind Treatment Period |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 3, 2019 | Aug 19, 2020 |
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| Levomilnacipran | Drug | Over-encapsulated levomilnacipran ER capsules administered orally on Day 1 to Week 8. |
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| Fluoxetine | Drug | Over-encapsulated fluoxetine tablets administered orally on Day 1 to Week 8. |
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| Baseline (Week 0) to Week 8 |
| Tucson |
| Arizona |
| 85724 |
| United States |
| Advanced Research Center, Inc. | Anaheim | California | 92801 | United States |
| ProScience Research Group | Culver City | California | 90230 | United States |
| Sun Valley Research Center | Imperial | California | 92251 | United States |
| Alliance for Research | Long Beach | California | 90807 | United States |
| Asclepes Research Centers | Panorama City | California | 91402 | United States |
| Syrentis Clinical Research | Santa Ana | California | 97025 | United States |
| Pacific Clinical Research Medical Group | Upland | California | 91786 | United States |
| MCB Clinical Research Center | Colorado Springs | Colorado | 80910 | United States |
| Florida Clinical Research Center; LLC | Bradenton | Florida | 34201 | United States |
| Coastal Clinical Research Specialists | Fernandina Beach | Florida | 32034 | United States |
| Gulfcoast Clinical Research Center | Fort Myers | Florida | 33912 | United States |
| Research in Miami Inc | Hialeah | Florida | 33013 | United States |
| Advanced Research Institute of Miami | Homestead | Florida | 33030 | United States |
| Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida | 32256 | United States |
| Innovative Clinical Research, Inc. | Lauderhill | Florida | 33319 | United States |
| Medical Research Group of Central Florida | Orange City | Florida | 32763 | United States |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32801 | United States |
| University of South Florida Board of Trustee | Tampa | Florida | 33613 | United States |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | United States |
| Institute for Behavioral Medicine | Smyrna | Georgia | 30080-2620 | United States |
| Clinical Research Institute | Stockbridge | Georgia | 30281 | United States |
| Sandeep Gaonkar, MD | Naperville | Illinois | 60563 | United States |
| NeuroMedical Institute | Panama | Illinois | 32405 | United States |
| Kentucky Pediatric Research | Bardstown | Kentucky | 40004 | United States |
| Adams Clinical Trials, LLC | Watertown | Massachusetts | 02472 | United States |
| Alivation Research | Lincoln | Nebraska | 68526 | United States |
| Kolade Research Institute | Las Vegas | Nevada | 89102 | United States |
| Healthy Perspectives - Innovative Mental Health Services. PLLC | Nashua | New Hampshire | 03060 | United States |
| Princeton Medical Institute | Princeton | New Jersey | 08540 | United States |
| Manhattan Behavioral Medicine | New York | New York | 10036 | United States |
| Midwest Clinical Research Center | Dayton | Ohio | 45417 | United States |
| Professional Psychiatric Services | Mason | Ohio | 45040 | United States |
| IPS Research Company | Oklahoma City | Oklahoma | 73106 | United States |
| Sooner Clinical Research | Oklahoma City | Oklahoma | 73112 | United States |
| Cutting Edge Research Group | Oklahoma City | Oklahoma | 73116 | United States |
| Paradigm Research Professionals | Oklahoma City | Oklahoma | 73118 | United States |
| Tulsa Clinical Research, LLC | Tulsa | Oklahoma | 74104 | United States |
| Oregon Center for Clinical Investigations, Inc. | Salem | Oregon | 97301 | United States |
| UTHSC-Houston | Houston | Texas | 77054 | United States |
| Bay Area Clinical Services dba Earle Research | Houston | Texas | 77058 | United States |
| Red Oak Psychiatry Associates | Houston | Texas | 77090 | United States |
| Family Psychiatry of The Woodlands | The Woodlands | Texas | 77381 | United States |
| UVA Child and Family Psychiatry Clinic | Charlottesville | Virginia | 22903 | United States |
| Carilion Medical Center | Roanoke | Virginia | 24014 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | United States |
| Eastside Therapeutic Resource dba Core Clinical | Everett | Washington | 98201 | United States |
| INSPIRA Clinical Research | San Juan | 00918 | Puerto Rico |
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. |
| FG002 | Levomilnacipran 80 mg/Day | 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. |
| FG003 | Fluoxetine 20 mg/Day | 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. |
| Safety Population |
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| COMPLETED |
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| NOT COMPLETED |
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| Double-blind Down-taper Period |
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Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | 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. |
| BG001 | Levomilnacipran 40 mg/Day | 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. |
| BG002 | Levomilnacipran 80 mg/Day | 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. |
| BG003 | Fluoxetine 20 mg/Day | 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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. | Intent to Treat (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. | Mean | Full Range | score on a scale |
| ||||||||
| Clinical Global Impression-Severity (CGI-S) Scale | The CGI-S is a clinician-rated scale used to rate the severity of the participant's current state of mental illness compared with major depressive disorder (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. | 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. | Mean | Full Range | score on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Week 0) to Week 8 |
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| Secondary | 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. | ITT Population included all participants in the Safety Population who had the baseline and at least 1 postbaseline assessment of the Children's Depression Rating Scale-Revised (CDRS-R) total score. Overall number of participants analyzed is the number of participants with data available for analyses. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Week 0) to Week 8 |
|
First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | 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. | 0 | 141 | 0 | 141 | 33 | 141 |
| EG001 | Levomilnacipran 40 mg/Day | 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. | 0 | 134 | 2 | 134 | 54 | 134 |
| EG002 | Levomilnacipran 80 mg/Day | 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. | 0 | 138 | 0 | 138 | 63 | 138 |
| EG003 | Fluoxetine 20 mg/Day | 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. | 0 | 134 | 4 | 134 | 41 | 134 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Overdose | Injury, poisoning and procedural complications | MedDRA : 22.0 | Systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA : 22.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA : 22.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA : 22.0 | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA : 22.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | MedDRA : 22.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA : 22.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA : 22.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA : 22.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA : 22.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA : 22.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA : 22.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA : 22.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA : 22.0 | Systematic Assessment |
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A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Allergan | 714-246-4500 | clinicaltrials@allergan.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Mar 25, 2019 | Aug 19, 2020 | Prot_001.pdf |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000078862 | Levomilnacipran |
| D005473 | Fluoxetine |
| ID | Term |
|---|---|
| D000078764 | Milnacipran |
| D003521 | Cyclopropanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011437 | Propylamines |
| D000588 | Amines |
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| MMRM |
| 0.8681 |
| LS Mean Difference |
| 0.26 |
| 2-Sided |
| 95 |
| -2.80 |
| 3.31 |
Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix. |
| Superiority |
| MMRM | 0.3439 | LS Mean | -1.47 | 2-Sided | 95 | -4.52 | 1.58 | Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix. | Superiority |
| OG002 | Levomilnacipran 80 mg/Day | 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. |
| OG003 | Fluoxetine 20 mg/Day | 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. |
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