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Changes in Hyperprolactinemia Secondary to Antipsychotics After Switching to Quetiapine

NCT00952757 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 35

Last updated 2009-08-07

No results posted yet for this study

Summary

Hyperprolactinaemia is a common side effect of some antipsychotics (APS), including some atypicals. Clinical consequences of hyperprolactinaemia are broad including amenorrhea, galactorrhea, tender breasts, gynecomastia and sexual dysfunction. Less known but also present is the increased cardiovascular risk, specially in women, disorders of osteoporotic type and a potential increased risk of breast and prostate cancer.

Despite this growing evidence, there are no consistent published data in order to adopt evidence-based decisions that may be beneficial for the patient.

This naturalistic observational 6 months follow-up study on patients with APS-induced hyperprolactinemia aims to obtain more information about the switching approach in cases of hyperprolactinemia secondary to APS and to better establish the role of switching to quetiapine (APS not related with the increase prolactin levels) in this problem.

Conditions

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Investigaciones Médicas Montejo S.L.

    lead OTHER

Principal Investigators

  • Ángel L Montejo, Dr · University of Salamanca

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • Spain

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00952757 on ClinicalTrials.gov