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Exploration of intervention measures for olanzapine-related metabolic syndrome

Exploration of intervention measures for olanzapine-related metabolic syndrome

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000031979
Enrollment
Unknown
Registered
2020-04-16
Start date
2020-05-07
Completion date
Unknown
Last updated
2020-04-20

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

Conditions

schizophrenia

Interventions

Control group :Olanzapine plus berberine placebo
experimental group 1:Olanzapine plus berberine
experimental group 2:Piperone instead of olanzapine

Sponsors

Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Hui'ai Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Structured clinical interview (SCID) of DSM-IV is used to meet the clinical diagnostic criteria of DSM-IV for schizophrenia or schizoaffective disorder; 2. For patients aged 18-45 years, the ratio of male to female is about 1:1; 3. Patients who meet the NCEP-ATP III standard of metabolic syndrome (MS) have the following three or more abnormalities: (1) waist >102 cm (male) or >88 cm (female); (2) TG >=1.70 mmol/L; (3) HDL-C =130 mmHg and/or DBP >=85 mmHg; (5) FPG >=6.1 mmol/L; 4. Patients who used olanzapine in the past, the dose of olanzapine remained unchanged and are still undergoing antipsychotic treatment for at least two months; 5. The total score of PANSS is less than 60 (1-7 point system); 6. At least one adult shall take care of the patients, record the drug intake, monitor the compliance of taking medicine and discover the adverse drug reactions in time; 7. Obtain the written informed consent of the patient. If the patient is unable to act during the onset of the disease, the written informed consent of his legal guardian is required.

Exclusion criteria

Exclusion criteria: 1. Patients with mood disorder, mental retardation, extensive developmental disorder, delirium, dementia, memory disorder or other cognitive disorders that meet DSM-IV diagnostic criteria; 2. Patients with severe unstable body diseases, patients with severe renal dysfunction and cardiac insufficiency, etc; 3. Patients with MRI contraindications (such as metal implants, pacemakers and severe claustrophobia) 4. Pregnant (screening for human chorionic gonadotropin in urine), lactating or dry expecting subjects who do not accept the use of effective contraceptive measures; 5. Patients with substance dependence on DSM-IV (except nicotine addiction); 6. Patients who had been treated with ECT in the first six months were selected; 7. Patients with serious suicide attempt or severe excitement; 8. There is sufficient evidence to show that patients with poor efficacy of two antipsychotic drugs with different mechanisms of action (the standard of poor efficacy is sufficient dose, sufficient treatment process, and complete compliance, patients still have serious mental symptoms); 9. Patients with contraindications to the antipsychotic drugs recommended in this study; Hemolytic anemia and glucose-6-phosphate dehydrogenase deficiency; 11. Patients who had a history of head injury with consciousness disorder for more than 5 minutes; 12. Those who are unable to cooperate with the conditions proposed by the sponsor or investigator; 13. Patients who are unable to take medicine according to the doctor's instructions or have no guardian.

Design outcomes

Primary

MeasureTime frame
body composition;Cranial mri;PANSS;HAMD-17;YMRS;Cognitive rating scale;

Secondary

MeasureTime frame
GAF;CGI;

Countries

China

Contacts

Public ContactLu Xiaobing

Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Hui'ai Hospital)

13688876346@139.com+86 13688876346

Outcome results

None listed

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