Vortioxetine Treatment Regimen for Major Depressive Disorder
Start vortioxetine at 10 mg once daily orally without regard to meals, then increase to 20 mg daily as tolerated for optimal efficacy. 1
Dosing Strategy
Initial Dosing
- Begin with 10 mg once daily as the recommended starting dose 1
- Administer without regard to meals 1
- For patients who cannot tolerate higher doses, consider reducing to 5 mg daily 1
Dose Optimization
- Increase to 20 mg daily for maximum therapeutic benefit, as this dose demonstrates superior efficacy 1, 2
- Vortioxetine 20 mg achieves symptomatic response (≥50% MADRS reduction) in 51.4% of patients versus 46.0% with 10 mg 2
- The 20 mg dose produces significantly faster response, with separation from placebo beginning at week 2, compared to week 6 for the 10 mg dose 2
- Sustained response from week 4 occurs in 26.0% of patients on 20 mg versus 19.1% on 10 mg 2
Special Populations
- Reduce dose by half in known CYP2D6 poor metabolizers (maximum 10 mg daily) 1
- When co-administered with strong CYP2D6 inhibitors, reduce vortioxetine dose by half 1
- With strong CYP inducers used for more than 14 days, consider increasing dose up to 3 times the original dose (not exceeding this maximum) 1
Treatment Duration
First Episode Depression
- Continue treatment for 4 to 9 months after achieving satisfactory response 3, 4
- Monitor response beginning within 1 to 2 weeks of initiation 3
- Modify treatment if inadequate response occurs within 6 to 8 weeks 3
Recurrent Depression
- For patients with 2 or more prior episodes, extend treatment duration beyond 9 months 3, 4
- Longer maintenance therapy is beneficial for preventing recurrence in this population 3
Discontinuation Protocol
- Vortioxetine can be discontinued abruptly without significant withdrawal symptoms 1
- For doses of 15 mg or 20 mg daily, taper to 10 mg daily for one week before full discontinuation when possible 1
- This tapering approach minimizes potential discontinuation symptoms 1
Clinical Considerations
Efficacy Profile
- Vortioxetine 20 mg demonstrates dose-dependent efficacy with remission rates (MADRS ≤10) of 32.0% versus 28.2% for 10 mg 2
- The medication shows efficacy as a second-step treatment option when switched from other antidepressants, with comparable outcomes to switching to bupropion SR, escitalopram, duloxetine, sertraline, or venlafaxine 3
Tolerability
- Most common adverse events include nausea, constipation, and vomiting (occurring in ≥5% of patients at twice the placebo rate) 1
- Rates of adverse events and treatment withdrawal do not increase during up-titration from 10 mg to 20 mg 2
- The 20 mg dose maintains tolerability despite superior efficacy 2
Safety Monitoring
- Screen for bipolar disorder before initiating treatment to avoid activation of mania/hypomania 1
- Monitor for serotonin syndrome, particularly when combined with other serotonergic agents 1
- Assess bleeding risk when co-administered with NSAIDs, antiplatelet agents, or anticoagulants 1
- Watch for hyponatremia, especially in elderly patients or those at risk for SIADH 1
- Closely monitor for suicidal thoughts and behaviors, particularly in young adults 1