schizophrenia
Conditions
Interventions
observation group:Palmitone Palmitate Injection (II) Medication Method: On the first day of treatment, the patient is injected with 351 mg of this product at the deltoid muscle site. After the initial
It is also possible to cross stop medication at a faster speed. Medication plan (as above).
(2) Switching from other oral antipsychotic drugs to Paliperidone Palmitate Injection (II) gradually reduces
Sponsors
Nanjing Brain Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Outpatient or inpatient patients with schizophrenia who meet the DSM-5 diagnostic criteria; 2.Age range of 18 to 65 years old (including boundary values), gender not limited; 3.Individuals who are currently receiving first or second generation oral antipsychotic medication (excluding clozapine) prior to screening, have been assessed by researchers to have a relatively stable condition, and have a PANSS total score of = 80 points during the screening period and baseline clinical evaluation; 4.Participants and/or their guardians who sign informed consent forms.
Exclusion criteria
Exclusion criteria: 1.The patient has been diagnosed with other mental illnesses besides schizophrenia; 2.Men with QTc interval>450ms and women with QTc interval>470ms; 3.History of abuse of psychoactive substances (excluding tobacco) in the past 12 months, with obvious suicidal tendencies or violent behavior; 4.Individuals who have had or currently have delayed onset motor disorders (TD), antipsychotic malignant syndrome (NMS), or severe extrapyramidal adverse reactions; 5.Patients with refractory schizophrenia, who have currently or previously used two or more antipsychotic drugs with different compounds but have not responded to sufficient treatment; 6.Individuals who have previously been allergic to risperidone or paliperidone or have had ineffective treatment; 7.Pregnant or lactating women or those planning to conceive; Or those who cannot guarantee the use of effective contraceptive measures during the study period; 8.Individuals who have received non convulsive electroconvulsive therapy within the past 3 months prior to enrollment; 9.Researchers believe that patients are not suitable for other situations in clinical research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive and Negative Symptom ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Personal and Social Performance Scale;Simpson-Angus Scale;Clinical Global Impression-Severty of Illness Scale;Barnes Akathisia Rating ;Abnormal Involuntary Movement ; | — |
Countries
China
Contacts
Public ContactYao Zhijian
Nanjing Brain Hospital
Outcome results
None listed