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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: Bromocriptin

Primary Measures

• Prolactin
• LH
• FSH
• Testosterone
• Estradiol

Secondary Measures

• PANSS
• HAM-D
• Simpson Angus Scale (SAS)

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University Hospital, Bonn

Overall Clinical Trial Officials and Contacts

Wolfgang Maier, MD Principal Investigator University of Bonn, Department of Psychiatry  

Overall Contact: Kai-Uwe Kuehn, MD 0049-(0)228-287-5681 kai-uwe.kuehn@ukb.uni-bonn.de

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00315081

Study ID Number: 150-05

ClinicalTrials.gov Identifier: NCT00315081

Health Authority: Germany: Federal Institute for Drugs and Medical Devices