Effects of Hyperprolactinemia Induced by Antipsychotic Drugs on Bone Metabolism

Sponsor

Shanghai Mental Health Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT03675750

Collaborator

(none)

120

Enrollment

Location

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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.

Study Design

Study Type:

Observational

Anticipated 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 :

Jul 1, 2018

Anticipated Primary Completion Date :

Apr 30, 2020

Anticipated Study Completion Date :

Oct 31, 2020

Outcome Measures

Primary Outcome Measures

Bone turnover biochemical markers [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

serum prolactin [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Mental Health Center	Shanghai	Shanghai	China

Sponsors and Collaborators

Shanghai Mental Health Center

Investigators

Principal Investigator: LiHua Wang, Shanghai Mental Health Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shanghai Mental Health Center

ClinicalTrials.gov Identifier:

NCT03675750

Other Study ID Numbers:

201740089

First Posted:

Sep 18, 2018

Last Update Posted:

Sep 19, 2019

Last Verified:

Jun 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Shanghai Mental Health Center

antipsychotic drugs

hyperprolactinemia

bone metabolism

Additional relevant MeSH terms:

Hyperprolactinemia

Schizophrenia

Study Results

No Results Posted as of Sep 19, 2019