Schizophrenia
Conditions
Interventions
Case series(Aripiprazole Oral Soluble Film):None
Sponsors
The Second People's Hospital of Hunan Province
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1)Outpatients or inpatients with schizophrenia who meet the diagnostic criteria of DSM-5 (2)Males or females aged between 18 and 65 (inclusive of both 18 and 65) (3)The total score of the Positive and Negative Syndrome Scale (PANSS) is >= 70 points; among the four types of symptoms in the PANSS scale (P1 - Delusion, P2 - Disorganized Thinking, P3 - Hallucinatory Behavior, P6 - Suspiciousness/Persecution), at least two types of positive symptoms are rated as >= 4 (moderate). (4)The subjects and their guardians signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1)The patient has a diagnosis of other mental disorders in addition to schizophrenia. (2)Those with severe physical diseases, mental retardation, mental disorders caused by brain organic and physical diseases, or other abnormal indicators (AST/ALT>= 2 times the upper limit of normal values, Cr > 1.2 times the upper limit of normal values, QTc interval > 450ms for men and > 470ms for women); (3)There is a history of abuse of psychoactive substances (excluding tobacco) in the past 12 months, with obvious suicidal tendencies or violent behaviors. (4)Those who have had or currently have tardive dyskinesia (TD), neuroleptic malignant syndrome (NMS) caused by antipsychotic drugs, or severe extrapyramidal adverse reactions; (5)Those who have had allergic reactions to any antipsychotic drugs in the past; (6)Those who have shown no response to aripiprazole treatment in the past; (7)Pregnant or lactating women or those planning to become pregnant; or those who cannot ensure the use of effective contraceptive measures during the study period; (8)Other situations where researchers consider patients unsuitable for clinical research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Positive and Negative Symptoms Scale, PANSS; | — |
Secondary
| Measure | Time frame |
|---|---|
| At the end of the study, the PANSS reduction rate and the effective rate were calculated.; | — |
Countries
China
Contacts
Public ContactYuan Ning
The Second People's Hospital of Hunan Province
Outcome results
None listed