Effects of Hyperprolactinemia Induced by Antipsychotic Drugs on Bone Metabolism

NCT03675750 | Unknown

• 1 other identifier: 201740089
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

antipsychotic drugs; hyperprolactinemia; bone metabolism

Outcome Measures

Primary Outcomes (1)

• Bone turnover biochemical markers

  changes in the level of serum bone alkaline phosphatase ,serum β-crosslaps and from baseline to 4, 8, 12 and 26 weeks after enrollment

  baseline ,4 weeks ,8 weeks，12 weeks and 26 weeks

Secondary Outcomes (1)

• serum prolactin

  baseline ,4 weeks ,8 weeks，12 weeks and 26 weeks

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Chinese outpatients or inpatients with schizophrenia

You may qualify if:

• \. 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

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum bone alkaline phosphatase ,serum β-crosslaps and prolactin

MeSH Terms

Conditions

Schizophrenia; Hyperprolactinemia

Condition Hierarchy (Ancestors)

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

Study Officials

• LiHua Wang

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LiHua Wang

CONTACT

18017311510; ashleyzhima@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2018
• First Posted: September 18, 2018
• Study Start: July 1, 2018
• Primary Completion: April 30, 2020
• Study Completion: October 31, 2020
• Last Updated: September 19, 2019

Record last verified: 2019-06

Locations

CN (1)