Schizophrenia spectrum disorders
Conditions
Interventions
experimental group:Long-acting injectable risperidone, 25 mg/2 weeks ~50mg/2 weeks, intramuscular injection.
Sponsors
Beijing Huilongguan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Outpatients or inpatients with schizophrenia spectrum disorder (excluding schizoid personality disorder) meeting DSM-5 diagnostic criteria (can be state diagnosis: hallucinatory, delusional, and hallucinatory delusional states); 2. Age 18 ~ 65 (including borderline values), regardless of gender. 3. A total score of >=70 on the Positive and Negative Symptom Scale (PANSS), and at least one of the following items scored >=4: P1 delusions, P2 conceptual disorder, P3 hallucinatory behavior, P6 suspicion/victimization, G9 unusual thought content. 4. Subjects or subjects for whom the guardian has signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. The presence of a diagnosis of mental illness other than schizophrenia spectrum disorder in the patient; 2. Those with severe physical illness, mental retardation, mental disorders due to organic brain and physical illness, or other index abnormalities (AST/ALT >= 2 times the upper limit of normal, Cr > 1.2 times the upper limit of normal, QTc interval > 450 ms in men and > 470 ms in women); 3. History of psychoactive substance abuse (excluding tobacco) in the past 12 months, significant suicidal ideation, or violent behavior; 4. Those with previous or current delayed movement disorder (TD), antipsychotic malignant syndrome (NMS), or severe extrapyramidal adverse reactions; 5. Patients with refractory schizophrenia, i.e., those who have failed after a full course of current or previous treatment with two or more antipsychotics of different compounds; 6. Those with previous allergy or treatment failure to risperidone or paliperidone; 7. Pregnant or lactating women or those who plan to become pregnant; or those who cannot be assured of effective contraception for the duration of the study; 8. Other conditions that, in the opinion of the investigator, make the patient unsuitable for clinical research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive and Negative Syndrome Scale (PANSS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Global Impression – Severity scale (CGI-S);Plasma concentration; | — |
Countries
China
Contacts
Public ContactTan Yunlong
Beijing Huilongguan Hospital
Outcome results
None listed