Risperidone-Induced Hyperprolactinemia Treated With Bromocriptine

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2005 by University Hospital, Bonn.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University Hospital, Bonn
ClinicalTrials.gov Identifier:
NCT00315081
First received: April 13, 2006
Last updated: NA
Last verified: November 2005
History: No changes posted
  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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   
Sponsors and Collaborators
University Hospital, Bonn
Investigators
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 August 20, 2014