ClinicalTrials.gg
Status unknownNCT03675750Updated Sep 19, 2019

Effects of Hyperprolactinemia Induced by Antipsychotic Drugs on Bone Metabolism

An observational study in Schizophrenia, sponsored by Shanghai Mental Health Center. Status unknown at 1 site in China. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-19.

Sponsored by Shanghai Mental Health Center · Observational

The sponsor has not verified this record recently (last verified Jun 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Schizophrenia

Keywords

  • antipsychotic drugs
  • hyperprolactinemia
  • bone metabolism
03

In context

Schizophrenia

3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.

This study's planned enrollment of 120 is below the median of 178 across 506 observational studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Shanghai Mental Health Center is the lead sponsor of 272 studies on the registry; 91 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Chinese outpatients or inpatients with schizophrenia

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

    1. Pregnant and breast feeding women 2. Abnormal lipid metabolism 3. The level of serum or aspartate aminotransferase is two times higher than the 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna
06

What researchers measure

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

    Time frame: baseline ,4 weeks ,8 weeks,12 weeks and 26 weeks

Secondary outcomes

  1. serum prolactin

    changes in the level of serum prolactin from baseline to 4, 8, 12 and 26 weeks after enrollment

    Time frame: baseline ,4 weeks ,8 weeks,12 weeks and 26 weeks

07

Study locations

1 of 1 sites recruiting
  • Shanghai Mental Health Center
    Shanghai, Shanghai, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03675750
Responsible party
Sponsor
First posted
Sep 18, 2018
Start date
Jul 1, 2018
Primary completion
Apr 30, 2020 (estimated)
Completion
Oct 31, 2020 (estimated)
Last update
Sep 19, 2019

Study contacts

LiHua Wang
Contact
ashleyzhima@163.com
18017311510
LiHua Wang
principal investigator · Shanghai Mental Health Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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