A Phase 3 interventional study of Bromocriptin in Schizophrenia and Hyperprolactinemia, sponsored by University Hospital, Bonn. Status unknown at 1 site in Germany. Open to male participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2006-04-17.
Sponsored by University Hospital, Bonn · Phase 3, Interventional, and Treatment
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.
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
This study's enrollment of 20 is below the median of 71 across 2,944 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →University Hospital, Bonn is the lead sponsor of 154 studies on the registry; 28 are open to participants now.
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Prolactin
LH
FSH
Testosterone
Estradiol
PANSS
HAM-D
Simpson Angus Scale (SAS)
The record gives a start of May 2006 and a completion of May 2008. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Nov 2005. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bromocriptine