Clinical Trial 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.
This study initiated by The first affiliated hospital of zhejiang university. Professor
Shao-hua Hu will be PI of the study. There are about 80 patients with bipolar II depressive
episode were involved in this study, all participants after 4 weeks of monotherapy
(quetiapine or lurasidone). Group A: Those patients who were treated effectively over the 4th
weekend {Reduction rate of 17 items of the Hamilton Depression Scale (HDS-17) >50%} continued
with the original regimen for 4 weeks. Subjects who did not meet valid criteria (HSDRS-17
subscore ratio<50%) were randomly assigned to two treatment groups: group B
(quetiapine/lurasidone + vortioxetine tablets) and group C (quetiapine/lurasidone + sodium
valproate sustained release tablets). Subjects in group B were given vortioxetine in
combination with their original treatment regimen at week 5; Subjects in group C began to
receive sodium valproate sustained-release tablets in combination with the original treatment
regimen at week 5. All three groups were observed at the end of the 16th week.
Group A: single drug treatment group: quetiapine tablet 300mg~600mg/d or Lurasidone tablet
40-120mg /d; Group B: quetiapine tablets 300mg~600mg/d or Lurasidone tablets 40-120mg /d+
vortioxetine 5-10mg /d Group C: quetiapine tablets 300mg~600mg/d or Lurasidone tablets
40-120mg /d+ sodium valproate sustained release tablets 0.5-1.0 /d Quetiapine or lurasidone
is currently the first-line treatment for bipolar II depressive episodes, ensuring effective
treatment for all subjects. The study program will last 16 weeks with seven study visits
including screening. For the consideration of scientific, legal and ethical factors, 100
subjects are initially planned to be enrolled in this experiment.
