Schizophrenia Clinical Trial
Official title:
Therapy With Bromocriptine in Patients With Symptomatic Risperidone-Induced Hyperprolactinemia
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.
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | May 2008 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 60 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | University of Bonn, Department of Psychiatry | Bonn | Northrhine-Westfalia |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bonn |
Germany,
Bliesener N, Yokusoglu H, Quednow BB, Klingmüller D, Kühn KU. Usefulness of bromocriptine in the treatment of amisulpride-induced hyperprolactinemia: a case report. Pharmacopsychiatry. 2004 Jul;37(4):189-91. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prolactin | |||
Primary | LH | |||
Primary | FSH | |||
Primary | Testosterone | |||
Primary | Estradiol | |||
Secondary | PANSS | |||
Secondary | HAM-D | |||
Secondary | Simpson Angus Scale (SAS) |
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