Trintellix (Vortioxetine) Indications
Trintellix is specifically indicated for the treatment of major depressive disorder (MDD) in adults. 1
Primary Indication
- Trintellix is FDA-approved exclusively for treating major depressive disorder in adults 1
- It is not approved for use in pediatric patients 1
- The recommended starting dose is 10 mg administered orally once daily without regard to meals 1
Mechanism of Action
- Vortioxetine is a multimodal antidepressant that functions through several mechanisms 2:
- Acts as a serotonin transporter (5-HTT) inhibitor
- Functions as an antagonist at 5-HT3, 5-HT1D, and 5-HT7 receptors
- Acts as an agonist at 5-HT1A receptors
- Functions as a partial agonist at 5-HT1B receptors 2
- This unique multimodal action distinguishes it from traditional SSRIs and SNRIs 2, 3
Efficacy Profile
- Vortioxetine has demonstrated efficacy in multiple clinical trials for the treatment of MDD 4
- It outperforms placebo in key efficacy outcomes including response rates (RR 1.35,95% CI 1.23-1.48) and remission rates (RR 1.33,95% CI 1.17-1.52) 4
- Treatment duration recommendations 5:
- For a first episode of MDD: continue treatment for 4-9 months after satisfactory response
- For patients with 2 or more episodes: longer duration therapy is beneficial
Cognitive Benefits
- Vortioxetine has demonstrated significant improvements in cognitive function compared to placebo (SMD 0.34,95% CI 0.16-0.52) 4
- It is the first antidepressant shown to effectively augment cognitive function in adults with severe depressive episodes, independent of its effects on mood 3
- The cognitive benefits may be related to its effects on hippocampal pyramidal cells, improving synaptic transmission and neuroplasticity 3
Safety and Tolerability
- Common adverse effects include 6:
- Nausea (NNH vs. placebo: 6,95% CI 6-7)
- Constipation (NNH vs. placebo: 64,95% CI 37-240)
- Vomiting (NNH vs. placebo: 28,95% CI 23-38)
- Vortioxetine has a favorable weight gain profile compared to some other antidepressants 6
- Like other antidepressants, it carries a boxed warning regarding increased risk of suicidal thoughts and behaviors in pediatric and young adult patients 1
Clinical Considerations
- Prior to initiating treatment, patients should be screened for bipolar disorder, mania, or hypomania 1
- For discontinuation of doses of 15-20 mg/day, it is recommended to decrease to 10 mg/day for one week before full discontinuation to minimize withdrawal symptoms 1
- Dose adjustments are necessary for CYP2D6 poor metabolizers or patients taking strong CYP2D6 inhibitors 1
- The maximum recommended dose is 20 mg/day; efficacy and safety of higher doses have not been evaluated in controlled clinical trials 1