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NCT03675750 Clinical Trial

Effects of Hyperprolactinemia Induced by Antipsychotic Drugs on Bone Metabolism

Schizophrenia Clinical Trial

Official title:
Effects of Hyperprolactinemia Induced by Antipsychotic Drugs on Bone Metabolism

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03675750
Other study ID # 201740089
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2018
Est. completion date October 31, 2020

Study information
Verified date June 2019
Source Shanghai Mental Health Center
Contact LiHua Wang
Phone 18017311510
Email ashleyzhima@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date October 31, 2020
Est. primary completion date April 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Shanghai Mental Health Center Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Bone turnover biochemical markers changes in the level of serum bone alkaline phosphatase ,serum ß-crosslaps and from baseline to 4, 8, 12 and 26 weeks after enrollment baseline ,4 weeks ,8 weeks,12 weeks and 26 weeks
Secondary serum prolactin changes in the level of serum prolactin from baseline to 4, 8, 12 and 26 weeks after enrollment baseline ,4 weeks ,8 weeks,12 weeks and 26 weeks
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