Risperidone-Induced Hyperprolactinemia Treated With Bromocriptine
Primary Purpose
Schizophrenia, Hyperprolactinemia
Status
Unknown status
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Bromocriptin
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Hyperprolactinemia, Risperidone, Bromocriptin
Eligibility 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
Sites / Locations
- University of Bonn, Department of Psychiatry
Outcomes
Primary Outcome Measures
Prolactin
LH
FSH
Testosterone
Estradiol
Secondary Outcome Measures
PANSS
HAM-D
Simpson Angus Scale (SAS)
Full Information
NCT ID
NCT00315081
First Posted
April 13, 2006
Last Updated
April 13, 2006
Sponsor
University Hospital, Bonn
1. Study Identification
Unique Protocol Identification Number
NCT00315081
Brief Title
Risperidone-Induced Hyperprolactinemia Treated With Bromocriptine
Official Title
Therapy With Bromocriptine in Patients With Symptomatic Risperidone-Induced Hyperprolactinemia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2005
Overall Recruitment Status
Unknown status
Study Start Date
May 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2008 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Bonn
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Hyperprolactinemia
Keywords
Schizophrenia, Hyperprolactinemia, Risperidone, Bromocriptin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Bromocriptin
Primary Outcome Measure Information:
Title
Prolactin
Title
LH
Title
FSH
Title
Testosterone
Title
Estradiol
Secondary Outcome Measure Information:
Title
PANSS
Title
HAM-D
Title
Simpson Angus Scale (SAS)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kai-Uwe Kuehn, MD
Phone
0049-(0)228-287-5681
Email
kai-uwe.kuehn@ukb.uni-bonn.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfgang Maier, MD
Organizational Affiliation
University of Bonn, Department of Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Bonn, Department of Psychiatry
City
Bonn
State/Province
Northrhine-Westfalia
ZIP/Postal Code
53105
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kai-Uwe Kuehn, MD
Phone
0049-(0)2228-287-5681
Email
kai-uwe.kuehn@ukb.uni-bonn.de
12. IPD Sharing Statement
Citations:
PubMed Identifier
15467977
Citation
Bliesener N, Yokusoglu H, Quednow BB, Klingmuller D, Kuhn KU. Usefulness of bromocriptine in the treatment of amisulpride-induced hyperprolactinemia: a case report. Pharmacopsychiatry. 2004 Jul;37(4):189-91. doi: 10.1055/s-2004-827176. No abstract available.
Results Reference
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Risperidone-Induced Hyperprolactinemia Treated With Bromocriptine
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