NCT04826510

Efficacy and Safety of Peropirone Hydrochloride Tablets in the Treatment of Adolescent Bipolar Disorder Depression

Objective to Evaluate the Efficacy and Safety of Peropirone Hydrochloride Tablets in the Treatment of Adolescent Bipolar Depressive Episode: a Multicenter Open Randomized Controlled Clinical Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 189 (estimated)
• Sponsor: Shanghai Mental Health Center · Academic / Other
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Participants will be randomly assigned to the lithium carbonate group, piperopirone hydrochloride group or the lithium carbonate + Piperopirone hydrochloride group after obtaining the corresponding random number according to the order of inclusion. According to the random centers, the lithium carbonate group: piperopirone hydrochloride group: lithium carbonate + Piperopirone hydrochloride group was 1:1:1

Conditions

• Depressive Disorder

Interventions

Type	Name	Description
DRUG	Perospirone hydrochloride tablets	The dosage of perospirone hydrochloride tablets was 16-36 mg / D for 8 weeks.
DRUG	Lithium carbonate + perospirone hydrochloride	The stable blood lithium concentration was 0.5-1.2 mmol / L, and the dose of perospirone hydrochloride tablets was 16-36 mg / D for 8 weeks.
DRUG	Lithium Carbonate Pill	Lithium carbonate treatment, stable blood lithium concentration 0.5-1.2 mmol / L, course of 8 weeks.

Timeline

• Start date: 2020-11-25
• Primary completion: 2021-06-30
• Completion: 2021-06-30
• First posted: 2021-04-01
• Last updated: 2021-04-01

Locations

1 site across 1 country: China