Schizophrenia Clinical Trial
Official title:
Therapy With Bromocriptine in Patients With Symptomatic Risperidone-Induced Hyperprolactinemia
Antipsychotic drugs can cause a clinically relevant hyperprolactinemia due to blocking the dopamine receptors in the pituitary.Schizophrenic patients suffering from a neuroleptic-induced hyperprolactinemia will be examined endocrinologically. Adverse drug effects and diagnoses will be confirmed by measuring hormones.
Antipsychotic drugs can cause a clinically relevant hyperprolactinemia due to blocking the
dopamine receptors in the pituitary.Depending on its concentration hyperprolactinemia causes
a median hypogonadism with estrogen insufficiency in women and testosterone insufficiency in
men by inhibiting the pulsatile GnRH-secretion.The hyperprolactinemia-induced symptoms have
been successfully medicated for years with dopamine agonists like bromocriptine.
In patients with psychiatric diseases hyperprolactinemia is usually not treated with
dopamine agonist fearing a reexacerbation of the underline psychiatric disease. In a few
studies and casuistically the treatment of neuroleptic-induced hyperprolactinemia with
bromocriptine has been shown to be effective without causing reexacerbation of psychotic
symptoms.
Schizophrenic patients suffering from a neuroleptic-induced hyperprolactinemia (in extremis
galactorrhoea and amenorrhoea. in women, loss of libido and erectile dysfunction in men)
will be examined endocrinologically. Adverse drug effects and diagnoses will be confirmed by
measuring hormones (prolactin, LH, FSH, testosterone, estradiol). In case of a clear
symptomatic, neuroleptic-induced hyperprolactinemia patients will be medicated with
bromocriptin. Therapeutical success will be determined endocrinologically in week 0, 1, 2,
3, 4, 8, 12, 16, 20 and 24 together with a psychiatric examination (PANSS, HAM-D,
Simpson-Angus Scale (SAS)). Safety of therapy will be ensured by the close meshed
psychiatric examinations.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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