Trintellix (Vortioxetine) Treatment for Major Depressive Disorder
The recommended treatment for major depressive disorder with Trintellix (vortioxetine) is to start at 10 mg once daily, then increase to 20 mg daily as tolerated, with 5 mg daily as an option for patients who cannot tolerate higher doses. 1
Dosing Recommendations
- The recommended starting dose is 10 mg administered orally once daily without regard to meals 1, 2
- The dose should be increased to 20 mg/day as tolerated, which is the most effective dose for treating MDD in the United States 1, 3
- Consider 5 mg/day for patients who do not tolerate higher doses 1, 3
- Maximum recommended dose is 10 mg/day in known CYP2D6 poor metabolizers 1, 4
- Dose adjustment is recommended when co-administered with strong CYP2D6 inhibitors (reduce dose by half) 1, 4
- Consider dose increase when co-administered with strong CYP inducers for more than 14 days (maximum recommended dose should not exceed 3 times the original dose) 1
Treatment Duration
- For patients with a first episode of MDD who achieve remission, continue treatment for 4-9 months after symptom resolution 5, 6
- For patients with 2 or more previous depressive episodes, longer duration therapy (years to lifelong) may be beneficial 5, 6
- Trintellix can be discontinued abruptly; however, it is recommended that doses of 15 mg/day or 20 mg/day be reduced to 10 mg/day for one week prior to full discontinuation if possible 1, 3
Monitoring and Follow-up
- Assess patient status, therapeutic response, and adverse effects regularly beginning within 1-2 weeks of treatment initiation 5, 6
- Closely monitor for increases in suicidal thoughts and behaviors, especially during the first 1-2 months of treatment 5, 1
- Monitor for emergence of agitation, irritability, or unusual changes in behavior 5
- Modify treatment if the patient does not have an adequate response to pharmacotherapy within 6-8 weeks 5
Efficacy and Maintenance
- All doses of vortioxetine (5 mg, 10 mg, and 20 mg) have been shown to significantly reduce the risk of relapse compared with placebo in patients with remitted MDD 7
- In a 52-week extension study, patients showed continued improvement in depression and anxiety symptoms, as well as overall functioning, throughout the treatment period with 15-20 mg doses 8
- The 20 mg dose has been shown to be the most effective dose for treating MDD in the United States 3
Adverse Effects and Safety Considerations
- Most common adverse reactions (≥5% and at least twice the rate of placebo) are nausea, constipation, and vomiting 1
- Nausea is the most common adverse event and is dose-dependent 3
- Boxed warning for increased risk of suicidal thoughts and behaviors in pediatric and young adult patients taking antidepressants 1
- Other warnings include risk of serotonin syndrome, increased risk of bleeding, activation of mania/hypomania, angle closure glaucoma, hyponatremia, and sexual dysfunction 1
Clinical Pitfalls to Avoid
- Don't assume that initial improvement means treatment can be discontinued early; premature discontinuation increases relapse risk 6
- Don't overlook the need to reassess treatment if no improvement is seen after 6-8 weeks of therapy 5, 6
- Avoid missing the opportunity for mental health consultation if patients achieve only partial improvement despite adequate treatment 6
- Be cautious when prescribing to patients with bipolar disorder due to risk of activating mania/hypomania 1