Efficacy, Safety, and Tolerability of Levomilnacipran ER in Pediatric (7-17 Years) With Major Depressive Disorder
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03569475|
Recruitment Status : Completed
First Posted : June 26, 2018
Last Update Posted : May 7, 2021
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: Levomilnacipran ER Drug: Fluoxetine Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||501 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Double-blind, Placebo- and Active-controlled Evaluation of the Safety and Efficacy of Levomilnacipran ER in Pediatric Patients 7-17 Years With Major Depressive Disorder|
|Actual Study Start Date :||July 6, 2018|
|Actual Primary Completion Date :||March 1, 2021|
|Actual Study Completion Date :||March 1, 2021|
Experimental: Levomilnacipran ER
patients will take levomilnacipran 10 mg/day on Days 1-3, 20 mg/day on Days 4-7, and 40 mg/day during weeks 2 through 8 of the double blinded treatment and 40 mg/day for 2 days, and then levomilnacipran 20 mg/day for 5 days in the down-taper period. Based on therapeutic response and tolerability, an additional dose increase to 80 mg/day is permitted at Week 3 through 8 of the double blinded treatment. in the down-taper period. the patient will take levomilnacipran 40 mg/day for 2 days, and then levomilnacipran 20 mg/day for 5 days
Drug: Levomilnacipran ER
During the double-blind treatment period, patients will take levomilnacipran 10 mg/day on Days 1-3, 20 mg/day on Days 4-7, and 40 mg/day during Weeks 2 through 8. Based on therapeutic response and tolerability, an additional dose increase to 80 mg/day is permitted at Week 3. During the down-taper period, patients will take levomilnacipran 40 mg/day for 2 days, and then levomilnacipran 20 mg/day for 5 days
Active Comparator: Fluoxetine 20 mg
Patients randomized to the Fluoxetine 20 mg arm will take Week 1, 10mg/day; week 2 through week 8, 20 mg/day
During the double-blind treatment period, patients will take Fluoxetine 10 mg/day on Days 1-7, and then 20 mg/day during Weeks 2 through Week 8. During the down-taper period, patients will take Fluoxetine 10 mg/day for 7 days.
Placebo Comparator: Placebo
Patients randomized to the placebo arm will take placebo capsules once daily through week 8
Patients randomized to the placebo arm will take placebo capsules once daily
- Change from baseline in Children's Depression Rating Scale- Revised (CDRS-R) [ Time Frame: week 8 ]The CDRS-R is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6-17 years and contains 17 ordinally-scaled items that evaluate the presence and severity of symptoms commonly associated with childhood depression. The CDRS-R total score ranges from 17 to 113.
- Change from baseline in Clinical Global Impression-Severity (CGI-S) scale [ Time Frame: Week 8 ]The CGI-S is a clinician-rated scale used to rate the severity of the patient's current state of mental illness compared with an MDD patient population. The patient will be rated on a scale from 1 to 7, with 1 indicating a "normal, not at all ill" and 7 indicating "among the most extremely ill patients."
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): NCT03569475
|Study Director:||Daniel Radecki, PhD||Allergan|