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Cohort study on the characteristics of TCM constitution and adverse metabolic reactions of antipsychotic drugs in patients with first-episode schizophrenia

Research on the characteristics of TCM constitution and adverse metabolic reactions of antipsychotic drugs in patients with first-episode schizophrenia

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2100004650
Enrollment
Unknown
Registered
2021-03-27
Start date
2021-05-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

schizophrenia

Interventions

Sponsors

Hangzhou Seventh Peoples Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1.ICD-10 diagnostic criteria for schizophrenia, schizoid psychosis or schizoaffective disorder; Hospitalized or outpatient patients; 2. No gender limitation, aged 18 to 40 years; 3.(1)The first attack, the course of disease is not more than 2 years; (2)The duration of continuous treatment for never taking medication or taking the same antipsychotic medication is <2 weeks, and the cumulative duration of antipsychotic exposure is <6 weeks.; 4. Able to complete questionnaires under the guidance of clinical researchers, use APP, agree to informed consent and participate voluntarily; 5. Body mass index (BMI) is not less than 17.0kg/m2; 6. No language or hearing impairment.

Exclusion criteria

Exclusion criteria: 1. Disease is not the diagnosis of schizophrenia, such as dissociation disorder, bipolar disorder, depression, schizoaffective disorder, etc.; 2. In the 6 months before screening, active substance dependence (excluding nicotine and caffeine dependence) was diagnosed; 3. Patients with a severe tendency to suicide within 12 months prior to screening or violence as clinically assessed during the screening; 4. Past or present suffering from any serious or unstable cardiovascular, respiratory, neurological (including epilepsy or major cerebrovascular), kidney, liver, blood, uncontrolled diabetes, glaucoma, or other system diseases. Coma, delirium, mild-to-moderate or severe mental retardation, there can result in long QT, ventricular tachycardia or sudden death risk factors; 5. The results of blood routine, biochemical, hematological and electrocardiogram examinations are not within the normal range of laboratory values and have clinical significance as judged by researchers; 6. Evidence of liver disease at the time of prior or screening; 7. Previous neuroblocker malignant syndrome (NMS) or tardive dyskinesia; 8. Women who are pregnant, breastfeeding or who plan to become pregnant within 6 months; 9. Patients with previous mental retardation or mental retardation; 10. Participated in other clinical studies within 30 days before screening.

Design outcomes

Secondary

MeasureTime frame
blood routine examination;routine urine test;hepatorenal function;electrocardiograph;

Countries

China

Contacts

Public ContactZhang Lina

Hangzhou Seventh Peoples Hospital

2064238482@qq.com+86 571 8758043379

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026