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Effects of Hyperprolactinemia Induced by Antipsychotic Drugs on Bone Metabolism

S

Shanghai Mental Health Center

Status

Unknown

Conditions

Schizophrenia

Study type

Observational

Funder types

Other

Identifiers

NCT03675750
201740089

Details and patient eligibility

About

The study is aimed to assess the severities of hyperprolactinemia caused by antipsychotic drugs and the effects of the duration of hyperprolactinemia on bone metabolism in schizophrenia patients.

Full description

Hyperprolactinemia is a common adverse effect of antipsychotic drugs. Studies have shown that hyperprolactinemia may affect bone metabolism through direct and indirect effects and increase the risk of osteoporosis and fracture.The investigators assess the duration, the severity of hyperprolactinemia and its effects on bone metabolism in schizophrenics taking antipsychotic drugs through analyzing the correlation between prolactin levels and biochemical markers of bone metabolism and the correlation between the duration of hyperprolactinemia and abnormal bone metabolism. Meanwhile, the investigators aims to obtain the boundary value of prolactin levels in patients with abnormal bone metabolism.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

    1. Diagnosis of the disease meets the ICD-10 diagnostic criteria for schizophrenia 2. Subjects Intend to use atypical antipsychotics 3. Age between 18 and 50 years of age

Exclusion criteria

    1. Pregnant and breast feeding women 2. Abnormal lipid metabolism 3. The level of serum alanine aminotransferase or aspartate aminotransferase is two times higher than the upper limit of the normal 4. Patients with diabetes or impaired fasting glucose 5. The level of prolactin is higher than normal 6. Patients taking drugs that affect bone metabolism (e.g. selective serotonin reuptake inhibitors antidepressants, antiepileptic drugs) 7. The level of creatinine is 1.2 times higher than the upper limit of the normal value

Trial contacts and locations

1

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Central trial contact

LiHua Wang

Data sourced from clinicaltrials.gov

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