Recommended Dosage and Treatment Plan for Trintellix (Vortioxetine) in Adults with Major Depressive Disorder
The recommended starting dose of Trintellix (vortioxetine) for adults with major depressive disorder is 10 mg administered orally once daily without regard to meals, with a subsequent increase to 20 mg/day as tolerated. 1
Initial Dosing and Titration
- Start with 10 mg once daily
- Increase to 20 mg/day as tolerated
- For patients who cannot tolerate higher doses, consider 5 mg/day 1
- Maximum recommended dose is 10 mg/day in known CYP2D6 poor metabolizers 1
Dose Adjustments for Special Populations
- CYP2D6 Poor Metabolizers: Maximum recommended dose is 10 mg/day 1
- With Strong CYP2D6 Inhibitors: Reduce Trintellix dose by half when coadministered 1
- With Strong CYP Inducers: Consider dose increase when coadministered for more than 14 days (maximum recommended dose should not exceed 3 times the original dose) 1
Treatment Duration
- First Episode of MDD: Continue treatment for 6-12 months after full symptom resolution 2
- Recurrent Depression (2+ episodes): Continue treatment for at least 2 years or longer 2
- Risk of recurrence increases significantly with each episode: 50% after first episode, 70% after second episode, and 90% after third episode 2
Discontinuation Protocol
- Trintellix can be discontinued abruptly
- However, for doses of 15 mg/day or 20 mg/day, it is recommended to reduce to 10 mg/day for one week prior to full discontinuation if possible 1
- Close follow-up should be maintained for at least 2-3 months after discontinuation due to high risk of relapse during this period 2
Monitoring and Follow-up
- Begin assessment of response 1-2 weeks after treatment initiation
- Regular monitoring for:
- Treatment response
- Side effects
- Suicidal thoughts/behaviors 2
- After achieving remission, monitor monthly for 6-12 months 2
Efficacy and Safety Profile
- Clinical trials have demonstrated Trintellix's efficacy in treating both emotional and physical symptoms of depression 3
- In an 8-week study, vortioxetine 20 mg showed significant reduction in Montgomery-Åsberg Depression Rating Scale (MADRS) total score compared to placebo (p=0.002) 4
- Most common adverse events (≥5% and at least twice the rate of placebo) are nausea, constipation, and vomiting 1
- Long-term treatment (52 weeks) with 15-20 mg doses has been shown to be safe and well-tolerated, with nausea and headache being the most common adverse events 5
Important Warnings and Precautions
- Boxed Warning: Increased risk of suicidal thoughts and behavior in pediatric and young adult patients 1
- Serotonin Syndrome: Increased risk when coadministered with other serotonergic agents 1
- Bleeding Risk: Concomitant use with aspirin, NSAIDs, antiplatelet drugs, warfarin, or other drugs affecting coagulation may increase risk 1
- Activation of Mania/Hypomania: Screen patients for bipolar disorder 1
- Hyponatremia: Can occur in association with SIADH 1
- Sexual Dysfunction: May cause symptoms of sexual dysfunction 1
Treatment Alternatives and Considerations
- The American College of Physicians recommends either cognitive behavioral therapy (CBT) or second-generation antidepressants as initial treatment for MDD 6, 2
- If inadequate response after 6-8 weeks, treatment modification should be considered 2
- For patients who did not achieve remission after an initial adequate trial with a second-generation antidepressant, switching to vortioxetine is one potential option, with similar efficacy to other switch strategies 6
Special Considerations for Comorbid Conditions
- Vortioxetine has shown effectiveness in reducing symptoms of both depression and anxiety in patients with severe MDD comorbid with severe generalized anxiety disorder 7
- For patients with comorbid anxiety, dose up-titration to 20 mg/day early in therapy may be beneficial and can be achieved without compromising tolerability 7