Risperidone-Induced Hyperprolactinemia Treated With Bromocriptine
Information source: University Hospital, Bonn
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia; Hyperprolactinemia
Intervention: Bromocriptin (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: University Hospital, Bonn Official(s) and/or principal investigator(s):
Wolfgang Maier, MD, Principal Investigator, Affiliation: University of Bonn, Department of Psychiatry
Overall contact:
Kai-Uwe Kuehn, MD, Phone: 0049-(0)228-287-5681, Email: kai-uwe.kuehn@ukb.uni-bonn.de
Summary
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.
Clinical Details
Official title: Therapy With Bromocriptine in Patients With Symptomatic Risperidone-Induced Hyperprolactinemia
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: ProlactinLH FSH Testosterone Estradiol
Secondary outcome: PANSSHAM-D Simpson Angus Scale (SAS)
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Female and male schizophrenic patients.
- Antipsychotic treatment with risperidone.
- Diagnosis of a clinically relevant hyperprolactinemia.
- No indication of disturbance of the somato-, cortico or thyreotropic hypophysis-axis
(IGF-1, cortisol, ACTH, TSH, FT3, FT4)
Exclusion Criteria:
- Severe somatic disease, especially coronary disease.
- Acute psychotic exacerbation.
- Pregnancy
Locations and Contacts
Kai-Uwe Kuehn, MD, Phone: 0049-(0)228-287-5681, Email: kai-uwe.kuehn@ukb.uni-bonn.de
University of Bonn, Department of Psychiatry, Bonn, Northrhine-Westfalia 53105, Germany; Not yet recruiting
Kai-Uwe Kuehn, MD, Phone: 0049-(0)2228-287-5681, Email: kai-uwe.kuehn@ukb.uni-bonn.de
Additional Information
Related publications: Bliesener N, Yokusoglu H, Quednow BB, Klingmüller D, Kühn KU. Usefulness of bromocriptine in the treatment of amisulpride-induced hyperprolactinemia: a case report. Pharmacopsychiatry. 2004 Jul;37(4):189-91.
Starting date: May 2006
Last updated: April 13, 2006
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