Ignite Creation Date:
2024-05-05 @ 4:48 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00315081
Status:
UNKNOWN
Last Update Posted:
2006-04-17
First Post:
2006-04-13
Brief Title:
Risperidone-Induced Hyperprolactinemia Treated With Bromocriptine
Sponsor:
University Hospital Bonn
Organization:
University Hospital Bonn
Study Overview
Official Title:
Therapy With Bromocriptine in Patients With Symptomatic Risperidone-Induced Hyperprolactinemia
Status:
UNKNOWN
Status Verified Date:
2005-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Antipsychotic drugs can cause a clinically relevant hyperprolactinemia due to blocking the dopamine receptors in the pituitarySchizophrenic 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 pituitaryDepending on its concentration hyperprolactinemia causes a median hypogonadism with estrogen insufficiency in women and testosterone insufficiency in men by inhibiting the pulsatile GnRH-secretionThe 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None