Trial record 1 of 1 for:
NCT02431806
Safety and Efficacy of Levomilnacipran ER in Adolescent Participants With Major Depressive Disorder
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| ClinicalTrials.gov Identifier: NCT02431806 |
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Recruitment Status :
Completed
First Posted : May 1, 2015
Results First Posted : September 7, 2020
Last Update Posted : September 7, 2020
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Sponsor:
Forest Laboratories
Information provided by (Responsible Party):
Forest Laboratories
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Major Depressive Disorder | Drug: Placebo Drug: Levomilnacipran Drug: Fluoxetine | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 552 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | June 23, 2015 |
| Actual Primary Completion Date : | August 19, 2019 |
| Actual Study Completion Date : | August 19, 2019 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Depression
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: 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.
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Drug: Placebo
Matched over-encapsulated placebo capsules administered orally on Day 1 to Week 8. |
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Experimental: Levomilnacipran 40 mg
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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Drug: Levomilnacipran
Over-encapsulated levomilnacipran ER capsules administered orally on Day 1 to Week 8.
Other Name: Fetzima |
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Experimental: Levomilnacipran 80 mg
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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Drug: Levomilnacipran
Over-encapsulated levomilnacipran ER capsules administered orally on Day 1 to Week 8.
Other Name: Fetzima |
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Active Comparator: Fluoxetine 20 mg
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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Drug: Fluoxetine
Over-encapsulated fluoxetine tablets administered orally on Day 1 to Week 8.
Other Name: Prozac |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale [ Time Frame: Baseline (Week 0) to Week 8 ]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.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 12 Years to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- 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
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02431806
Locations
Show 49 study locations
Sponsors and Collaborators
Forest Laboratories
Investigators
| Study Director: | Daniel Radecki | Forest Research Institute, Inc., an affiliate of Allergan, plc |
Study Documents (Full-Text)
Documents provided by Forest Laboratories:
Documents provided by Forest Laboratories:
Statistical Analysis Plan [PDF] October 3, 2019
Study Protocol [PDF] March 25, 2019
| Responsible Party: | Forest Laboratories |
| ClinicalTrials.gov Identifier: | NCT02431806 |
| Obsolete Identifiers: | NCT03087916 |
| Other Study ID Numbers: |
LVM-MD-11 |
| First Posted: | May 1, 2015 Key Record Dates |
| Results First Posted: | September 7, 2020 |
| Last Update Posted: | September 7, 2020 |
| Last Verified: | August 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders Behavioral Symptoms Milnacipran Fluoxetine Levomilnacipran Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents |
Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Cytochrome P-450 CYP2D6 Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors Serotonin and Noradrenaline Reuptake Inhibitors Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |