Risperidone-Induced Hyperprolactinemia Treated With Bromocriptine
Keywords
Abstract
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.
Dates
| Last Verified: | 10/31/2005 |
| First Submitted: | 04/12/2006 |
| Estimated Enrollment Submitted: | 04/12/2006 |
| First Posted: | 04/16/2006 |
| Last Update Submitted: | 04/12/2006 |
| Last Update Posted: | 04/16/2006 |
| Actual Study Start Date: | 04/30/2006 |
| Estimated Study Completion Date: | 04/30/2008 |
Condition or disease
Intervention/treatment
Drug: Bromocriptin
Phase
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | Male |
| Accepts Healthy Volunteers | Yes |
| 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 |
Outcome
Primary Outcome Measures
1. Prolactin [undefined]
2. LH [undefined]
3. FSH [undefined]
4. Testosterone [undefined]
5. Estradiol [undefined]
Secondary Outcome Measures
1. PANSS [undefined]
2. HAM-D [undefined]
3. Simpson Angus Scale (SAS) [undefined]
