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Biological mechanisms of aripiprazole in alleviating olanzapine-induced metabolic syndrome in patients with schizophrenia

Biological mechanisms of aripiprazole to alleviate olanzapine-induced metabolic susceptibility in patients with schizophrenia

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400087706
Enrollment
Unknown
Registered
2024-08-01
Start date
2023-04-27
Completion date
Unknown
Last updated
2024-08-05

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

Conditions

schizophrenia

Interventions

Study Group ( Aripiprazole instead of olanzapine):NA
control group 1 (Single aripiprazole treatment with stable disease):NA
control group 2 (Single olanzapine treatment with stable disease :NA

Sponsors

Wuhan Mental Health Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Study group inclusion criteria: 1) Meets the diagnostic criteria for schizophrenia in the U.S. Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5); 2) Previously treated with OLZ monotherapy and currently stabilized with a PANSS score of <70; (3) Meet the diagnostic criteria of the Chinese Medical Association Diabetes Branch 2020 on metabolic syndrome [at least three of the following: (1) abdominal obesity (i.e., central obesity): waist circumference =90 cm for men and =85 cm for women; (2) hyperglycemia: fasting blood glucose =6.1 mmol/L or blood glucose =7.8 mmol/L at 2 h after glycemic load and/or diabetes mellitus that has already been diagnosed and treated Those with hypertension; (3) hypertension: blood pressure = 130/85 mmHg (1 mmHg=0.133 kPa) and/or those who have been recognized and treated for hypertension; (4) fasting TG = 1.70 mmol/L; (5) fasting HDL-C < l.04 mmol/L]. (4) Age 18-45 years, willingness to improve metabolic syndrome, and ability to cooperate in signing the informed consent; (5) Psychiatric history of less than 6 years, medical history in which ARI has not proved ineffective for the patient, and consent to alternative treatment of OLZ with ARI as the target drug. Control group 1 inclusion criteria: 1) Fulfilment of the diagnostic criteria for schizophrenia in the US Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5); 2) Single aripiprazole treatment for no shorter than 2 months at any dose; 3) Age 18-45 years old, stable condition, nno antipsychotic dose type or dose adjustment for at least 8 weeks, and PANSS score <70; 4) Not meeting the diagnostic criteria for metabolic syndrome and not comorbid with severe somatic diseases. Control group 2 inclusion criteria: 1) Fulfilment of the diagnostic criteria for schizophrenia in the US Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5); 2) Single olanzapine treatment for no shorter than 2 months at any dose; 3) Age 18-45 years old, stable condition, no antipsychotic dose type or dose adjustment for at least 8 weeks, and PANSS score <70; 4) Not meeting the diagnostic criteria for metabolic syndrome and not comorbid with severe somatic diseases.

Exclusion criteria

Exclusion criteria: Refractory schizophrenia with poor prior efficacy of aripiprazole, comorbidities with other serious physical illnesses, where the patient is at risk for suicide or harm to others; history of organic brain disease and significant physical illness; consistent with diagnosis of other psychiatric disorders, such as affective disorders, depression, and other psychiatric disorders; and evidence of medication dependence and psychoactive substance use.

Design outcomes

Primary

MeasureTime frame
Metabolic syndrome;

Secondary

MeasureTime frame
Enterobacteriology;Fasting insulin;Leptin;Orexin A;PCSK9;ABCG1 methylation;

Countries

China

Contacts

Public ContactJun Ma

Wuhan Mental Health Center

majun0313@wo.cn+86 131 2992 5008

Outcome results

None listed

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