Vortioxetine Adjunctive Treatment in Bipolar Depression
Status:
Active, not recruiting
Trial end date:
2023-06-30
Target enrollment:
Participant gender:
Summary
Depressive episode of bipolar disorder is often the first symptom of patients with bipolar
disorder, which is characterized by frequent recurrence, relatively long duration, high
comorbidity rate and high fatality rate. People with bipolar disorder spend a third of their
lives depressed, and it is these depressive symptoms that lead to long-term disability and
early death. The treatment of bipolar depression is controversial. The latest Mood Disorders
CPG guidelines recommend first-line therapy: quetiapine, lurasidone, lithium, valproate,
lamotrigine monotherapy or combination of quetiapine, lurasidone plus Mood stabilizer,
olanzapine plus fluoxetine therapy. In addition, the use of antidepressants is still
controversial, and their efficacy, prognosis and risk of mania remain to be evaluated.
Vortioxetine is a novel antidepressant with unique characteristics, and its multi-mode
mechanism of action can be used to treat a wide spectrum of symptoms of depression. Current
clinical experience suggests that the clinical conversion rate of vortioxetine is low, and
the depressive symptoms and cognitive symptoms of people with depressive episodes are
significantly improved. As of September 2019, a total of 4.87 million patient years (nearly 3
months of treatment with 20 million patients) were treated with vortioxetine in PSUR
(Periodic Safety Update), with 51 reported cases of hypomania and 322 reported cases of
mania. Based on the above data, the post-marketing conversion rate of vortioxetine is
approximately 1 in 10,000 patient-years or 1 in 40,000 patients. Therefore, the efficacy and
risk of transferring to mania of vortioxetine in bipolar II depressive episode deserve
further investigation.