Risperidone-Induced Hyperprolactinemia Treated With Bromocriptine
Recruitment status was Not yet recruiting
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Therapy With Bromocriptine in Patients With Symptomatic Risperidone-Induced Hyperprolactinemia |
- Prolactin
- LH
- FSH
- Testosterone
- Estradiol
- PANSS
- HAM-D
- Simpson Angus Scale (SAS)
| 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:
- 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
Contacts and Locations| Contact: Kai-Uwe Kuehn, MD | 0049-(0)228-287-5681 | kai-uwe.kuehn@ukb.uni-bonn.de |
| Germany | |
| University of Bonn, Department of Psychiatry | Not yet recruiting |
| Bonn, Northrhine-Westfalia, Germany, 53105 | |
| Contact: Kai-Uwe Kuehn, MD 0049-(0)2228-287-5681 kai-uwe.kuehn@ukb.uni-bonn.de | |
| Principal Investigator: | Wolfgang Maier, MD | University of Bonn, Department of Psychiatry |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00315081 History of Changes |
| Other Study ID Numbers: | 150-05 |
| Study First Received: | April 13, 2006 |
| Last Updated: | April 13, 2006 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by University Hospital, Bonn:
|
Schizophrenia Hyperprolactinemia Risperidone Bromocriptin |
Additional relevant MeSH terms:
|
Hyperprolactinemia Schizophrenia Hyperpituitarism Pituitary Diseases Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Endocrine System Diseases Schizophrenia and Disorders with Psychotic Features Mental Disorders Bromocriptine Risperidone Antiparkinson Agents Anti-Dyskinesia Agents |
Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Dopamine Agonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Antagonists Serotonin Agents Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants |
ClinicalTrials.gov processed this record on June 18, 2013