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Levomilnacipran · 1 trial · 1 indication
The CDRS-R is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6-17 years. It contains 17 ordinally-scaled items that evaluate the 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.
| Arm | Type | Description |
|---|---|---|
| Levomilnacipran ER 40-80 mg/day | EXPERIMENTAL | Levomilnacipran extended release (ER) capsules, orally, 10 milligram per day (mg/day) on Days 1 to 3, 20 mg/day on Days 4 to 7, and 40 mg/day from Week 2 through Week 8 of the Double-blind Treatment Period followed by levomilnacipran ER 40 mg/day on Days 1 and 2, and then 20 mg/day from Day 3 through Day 7 in the Down-taper Period. Based on therapeutic response and tolerability, an additional dose increase to 80 mg/day was permitted at Week 3 of the Double-blind Treatment Period. |
| Fluoxetine 20 mg/day | ACTIVE_COMPARATOR | Fluoxetine capsule, orally, 10 mg/day at Week 1, and 20 mg/day from Week 2 through Week 8 of the Double-blind Treatment Period followed by fluoxetine 10 mg/day from Day 1 through Day 7 of the Down-taper Period. |
| Placebo | PLACEBO_COMPARATOR | Matching placebo capsules once daily through 8 weeks in the Double-blind Treatment Period and Days 1 through 7 in the Down-taper Period. |
| Name | Type | Description |
|---|---|---|
| Levomilnacipran ER | DRUG | Levomilnacipran extended-release oral capsules |
| Fluoxetine | DRUG | Fluoxetine oral capsules |
| Placebo | DRUG | Matching placebo oral capsules |
Inclusion Criteria: * Patients must meet Diagnostic and statistical manual of mental disorders fifth edition (DSM-5) criteria for MDD, confirmed by Kiddie Schedule for Affective Disorders - Present and Lifetime (K-SADS-PL) * Patients must have a score ≥ 40 on the Children's Depression Rating Scale-...
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Levomilnacipran is used for the treatment of Major Depressive Disorder (MDD). It is being studied in a Phase 3 clinical trial for pediatric patients aged 7 to 17 years with this condition. The drug is a small molecule developed by AbbVie Inc. (ABBV).
Levomilnacipran is a small molecule being developed for Major Depressive Disorder. Its specific molecular target has not been disclosed in the available information. The drug is being evaluated in a Phase 3 trial for its efficacy, safety, and tolerability in pediatric patients.
Levomilnacipran is developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The company is conducting a Phase 3 clinical trial of Levomilnacipran for Major Depressive Disorder in pediatric patients.
Levomilnacipran is in Phase 3 clinical development. It is being investigated for the treatment of Major Depressive Disorder in pediatric patients aged 7 to 17 years. The drug is not approved and remains investigational, with one completed Phase 3 trial.
Levomilnacipran has one completed Phase 3 trial, NCT03569475, titled 'Efficacy, Safety, and Tolerability of Levomilnacipran ER in Pediatric Patients (7-17 Years) With Major Depressive Disorder.' This randomized, double-blind, placebo-controlled study enrolled 501 participants in the United States.
Levomilnacipran is a distinct drug from milnacipran, though both are used for depression. Levomilnacipran is the active enantiomer of milnacipran, meaning it is a specific form of the molecule. It is being developed by AbbVie for Major Depressive Disorder in pediatric patients.