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| Sponsor: | University Hospital, Bonn |
|---|---|
| Information provided by: | University Hospital, Bonn |
| ClinicalTrials.gov Identifier: | NCT00315081 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia Hyperprolactinemia |
Drug: Bromocriptin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Therapy With Bromocriptine in Patients With Symptomatic Risperidone-Induced Hyperprolactinemia |
| Estimated Enrollment: | 20 |
| Study Start Date: | May 2006 |
| Estimated Study Completion Date: | May 2008 |
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| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Kai-Uwe Kuehn, MD | 0049-(0)228-287-5681 | kai-uwe.kuehn@ukb.uni-bonn.de |
| Germany, Northrhine-Westfalia | |
| University of Bonn, Department of Psychiatry | |
| Bonn, Northrhine-Westfalia, Germany, 53105 | |
| Principal Investigator: | Wolfgang Maier, MD | University of Bonn, Department of Psychiatry |
More Information
| Study ID Numbers: | 150-05 |
| Study First Received: | April 13, 2006 |
| Last Updated: | April 13, 2006 |
| ClinicalTrials.gov Identifier: | NCT00315081 History of Changes |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
Schizophrenia Hyperprolactinemia Risperidone Bromocriptin |
|
Pituitary Diseases Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Hormone Antagonists Physiological Effects of Drugs Psychotropic Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiparkinson Agents Brain Diseases Dopamine Agonists Schizophrenia Serotonin Antagonists Hyperpituitarism Mental Disorders |
Therapeutic Uses Hyperprolactinemia Schizophrenia and Disorders with Psychotic Features Bromocriptine Hypothalamic Diseases Tranquilizing Agents Nervous System Diseases Risperidone Central Nervous System Depressants Endocrine System Diseases Central Nervous System Diseases Dopamine Antagonists Antipsychotic Agents Pharmacologic Actions Serotonin Agents |