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

Phase 1

Recruiting

• Conditions: schizophrenia

• Registration Number: ITMCTR2100004650
• Lead Sponsor: Hangzhou Seventh Peoples Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Observational study
• Study Design: Not specified