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Effects of Hyperprolactinemia Induced by Antipsychotic Drugs on Bone Metabolism

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ClinicalTrials.gov Identifier: NCT03675750
Recruitment Status : Recruiting
First Posted : September 18, 2018
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Shanghai Mental Health Center

Brief 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.

Condition or disease
Schizophrenia

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Hyperprolactinemia Induced by Antipsychotic Drugs on Bone Metabolism
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia




Primary Outcome Measures :
  1. Bone turnover biochemical markers [ Time Frame: baseline ,4 weeks ,8 weeks,12 weeks and 26 weeks ]
    changes in the level of serum bone alkaline phosphatase ,serum β-crosslaps and from baseline to 4, 8, 12 and 26 weeks after enrollment


Secondary Outcome Measures :
  1. serum prolactin [ Time Frame: baseline ,4 weeks ,8 weeks,12 weeks and 26 weeks ]
    changes in the level of serum prolactin from baseline to 4, 8, 12 and 26 weeks after enrollment


Biospecimen Retention:   Samples Without DNA
serum bone alkaline phosphatase ,serum β-crosslaps and prolactin


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Chinese outpatients or inpatients with schizophrenia
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03675750


Contacts
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Contact: LiHua Wang 18017311510 ashleyzhima@163.com

Locations
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China, Shanghai
Shanghai Mental Health Center Recruiting
Shanghai, Shanghai, China
Contact: LiHua Wang    18017311510    ashleyzhima@163.com   
Sponsors and Collaborators
Shanghai Mental Health Center
Investigators
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Principal Investigator: LiHua Wang Shanghai Mental Health Center

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Responsible Party: Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT03675750     History of Changes
Other Study ID Numbers: 201740089
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Mental Health Center:
antipsychotic drugs
hyperprolactinemia
bone metabolism
Additional relevant MeSH terms:
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Hyperprolactinemia
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs