Clinical Trial: Changes in Hyperprolactinemia Secondary to Antipsychotics After Switching to Quetiapine

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Changes in Hyperprolactinemia Secondary to Antipsychotics After Switching to Quetiapine: a Naturalistic, Prospective, Multicentric Observational Study of 6 Months Follow-u

Brief 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.

Detailed Summary:

Hyperprolactinaemia is a common side effect of some antipsychotics (APS), including some atypicals. Clinical consequences of hyperprolactinaemia include most remarkably the appearance of amenorrhea, galactorrhea, tender breasts, and gynecomastia - associated with dysmorphophobia and psychological disorders in some cases, particularly in men-. Another common side effect is sexual dysfunction, with decreased libido, anorgasmia, and in men, impotence, reduced volume ejaculated and even backward ejaculation. Less known but also present is the increased cardiovascular risk, specially in women, disorders of osteoporotic type. Furthermore, several authors have related hyperprolactinemic states with the development of breast cancer including a potential worse prognosis of it (Mandala, 1999; Clevenger 2003; Mujagic, 2004), and with the development of metastatic prostate cancer and resistance to hormone therapy in men (Lisonni, 2005)

Despite this growing evidence and the fact that APS with no apparent increase of prolactin levels exist, such as quetiapine or aripiprazole, many clinicians don't even monitor prolactin levels in patients following APS treatment. And when they do, they find 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 in this problem.

Sponsor: Investigaciones Médicas Montejo S.L.

Current Primary Outcome: Variation in prolactin serum levels after switching to quetiapine [ Time Frame: From baseline to endpoint (month 6) ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Changes in the clinical symptoms related to hyperprolactinemia [ Time Frame: Baseline to endpoint (month 6) ]

Original Secondary Outcome: Same as current

Information By: Investigaciones Médicas Montejo S.L.

Dates:
Date Received: August 3, 2009
Date Started: June 2007
Date Completion:
Last Updated: August 5, 2009
Last Verified: August 2009