Trintellix(vortioxetine)
Psychiatry· 350 cited findings· 1 source document
What the regulatory reviews say
Trintellix (vortioxetine) is indicated for the treatment of major depressive disorder (MDD) in adults. The recommended starting dose is 10 mg, with a potential increase to 20 mg/day. For patients who do not tolerate higher doses, a 5 mg/day dose is available. Discontinuation from 15 mg/day or 20 mg/day should involve a reduction to 10 mg/day for one week. The maximum recommended dose for CYP2D6 poor metabolizers is 10 mg/day.
In terms of efficacy, vortioxetine demonstrated a statistically significant improvement in CSFQ-14 total score change from Baseline compared to escitalopram at Week 4 (p=0.004) and Week 8 (p=0.013). At Week 8, the CSFQ-14 total score change from Baseline was 6.6 points for escitalopram versus 8.8 points for vortioxetine, with an LS mean difference of 2.2 points. Significant improvements favoring vortioxetine were also observed in the shift from abnormal to normal CSFQ-14 at Week 6 (p=0.013) and Week 8 (p=0.018) compared to escitalopram. CSFQ-14 responders were significantly greater in the vortioxetine group versus escitalopram at Week 8 (p=0.030).
Common adverse reactions (incidence ≥5% and at least twice the rate of placebo) included nausea, constipation, and vomiting. Symptoms of mania/hypomania were reported in <0.1% of patients in premarketing clinical studies. The lowest serum sodium reported in a subject treated with TRINTELLIX was 110 mmol/L. The drug received approval on October 19, 2018.
Key figures — cited to the source page
| CSFQ-14 total score change from Baseline (vortioxetine vs escitalopram) at Week 8 | 8.8 points (vortioxetine) vs 6.6 points (escitalopram) | Takeda Pharmaceutical Company Limited — Trintellix FDA Revie, p.79 |
| CSFQ-14 total score change from Baseline (LS mean difference vs escitalopram) at Week 8 | 2.2 points | Takeda Pharmaceutical Company Limited — Trintellix FDA Revie, p.79 |
| Shift from abnormal to normal CSFQ-14 (vortioxetine vs escitalopram) at Week 6 | significantly greater in the vortioxetine group (p=0.013) | Takeda Pharmaceutical Company Limited — Trintellix FDA Revie, p.82 |
| Most common adverse reactions (incidence ≥5% and at least twice the rate of placebo) | nausea, constipation and vomiting | Takeda Pharmaceutical Company Limited — Trintellix FDA Revie, p.9 |
| Symptoms of mania/hypomania reported in premarketing clinical studies | <0.1 % | Takeda Pharmaceutical Company Limited — Trintellix FDA Revie, p.15 |
| Lowest serum sodium reported in a subject treated with TRINTELLIX | 110 mmol/L | Takeda Pharmaceutical Company Limited — Trintellix FDA Revie, p.15 |
| Approval Date | October 19, 2018 | Takeda Pharmaceutical Company Limited — Trintellix FDA Revie, p.1 |
| Recommended starting dose | 10 mg | Takeda Pharmaceutical Company Limited — Trintellix FDA Revie, p.9 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.