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Risperidone-Induced Hyperprolactinemia Treated With Bromocriptine
This study is not yet open for participant recruitment.
Verified by University Hospital, Bonn, November 2005
First Received: April 13, 2006   No Changes Posted
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Bonn:

Primary Outcome Measures:
  • Prolactin
  • LH
  • FSH
  • Testosterone
  • Estradiol

Secondary Outcome Measures:
  • PANSS
  • HAM-D
  • Simpson Angus Scale (SAS)

Estimated Enrollment: 20
Study Start Date: May 2006
Estimated Study Completion Date: May 2008
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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00315081

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

Locations
Germany, Northrhine-Westfalia
University of Bonn, Department of Psychiatry
Bonn, Northrhine-Westfalia, Germany, 53105
Sponsors and Collaborators
University Hospital, Bonn
Investigators
Principal Investigator: Wolfgang Maier, MD University of Bonn, Department of Psychiatry
  More Information

Publications:
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

Keywords provided by University Hospital, Bonn:
Schizophrenia
Hyperprolactinemia
Risperidone
Bromocriptin

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on February 08, 2010