Schizophrenia Clinical Trial
Official title:
Changes in Hyperprolactinemia Secondary to Antipsychotics After Switching to Quetiapine: a Naturalistic, Prospective, Multicentric Observational Study of 6 Months Follow-up
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.
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.
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Observational Model: Case-Only, Time Perspective: Prospective
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