Risperidone-Induced Hyperprolactinemia Treated With Bromocriptine

Study Overview
=================
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.

Official Title
-----------------
Therapy With Bromocriptine in Patients With Symptomatic Risperidone-Induced Hyperprolactinemia

Conditions
-----------------
Schizophrenia, Hyperprolactinemia

Intervention / Treatment
-----------------
* Drug: Bromocriptin


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Bromocriptin|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prolactin |  |  | 
| LH |  |  | 
| FSH |  |  | 
| Testosterone |  |  | 
| Estradiol |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PANSS |  |  | 
| HAM-D |  |  | 
| Simpson Angus Scale (SAS) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, Hyperprolactinemia, Risperidone, Bromocriptin