Efficacy and Safety of Peropirone Hydrochloride Tablets in the Treatment of Adolescent Bipolar Disorder Depression
Status:
Recruiting
Trial end date:
2021-06-30
Target enrollment:
Participant gender:
Summary
Bipolar disorder, a type of mood disorder that occurs in various forms, such as depression,
mania, hypomania or irregularity.According to the World Health Organization mental health
survey, the lifetime prevalence of bipolar disorder is 2.4%; the 12-month prevalence was
1.5%. The lifetime incidence in Shenzhen was 1.5%, and the 12-month incidence was 1.1%. In
another study in Hong Kong, the 12-month prevalence of bipolar I, II, and "soft" II was 1.4%,
0.5%, and 1.8%, respectively. Due to endocrine effects, bipolar disorder is more common in
women than men, and mainly occurs in late adolescence and early adulthood, with an early
trend. An investigation involving 23 countries around the world found that the average age of
onset of bipolar disorder was 25 years old, and the low age group (17.24±3.20 years old)
accounted for 41.7%. Another study in the United States showed that the average age of onset
of bipolar disorder was 20 years old, and the low age group (14.5±4.9 years old) accounted
for 63%. With the improvement of medical level, the diagnosis rate of bipolar disorder is
getting closer to the true prevalence rate.
Without active treatment, the symptoms of bipolar disorder, especially depression, will
accompany the patients for a long time. The quality of life of patients is seriously
affected.
The safety of piperopilon hydrochloride has been widely recognized from pre-market clinical
research to post-market clinical practice. A total of a clinical study involving 1191
patients showed that the incidence of side effects from long-term use of piperopilone was
21.3%, and the main side effects were mild in the nervous and digestive systems. In addition,
it has been reported that piperopirone is also safe and effective for adolescents.Therefore,
the investigators designed this study to explore the atypical antipsychotic drug piperopirone
as a monotherapy or in combination with mood stabilizer.Clinical efficacy and safety of
lithium acid in the treatment of depressive episodes in adolescents with bipolar disorder,
and its improvement in cognitive function were assessed.The goal is to evaluate the efficacy
and safety of piperopilone hydrochloride tablets in the treatment of bipolar depressive
episode in adolescents.