Risperidone-Induced Hyperprolactinemia Treated With Bromocriptine

Phase 3

• Conditions: Schizophrenia; Hyperprolactinemia

• Registration Number: NCT00315081
• Lead Sponsor: University Hospital, Bonn

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.

Study Timeline

• Status Verified: 2005-11
• Study First Submitted: 2006-04-13
• Study First Submitted QC: 2006-04-13
• Last Update Submitted: 2006-04-13
• Study First Posted: 2006-04-17
• Last Update Posted: 2006-04-17
• Study Start: 2006-05
• Study Completion: 2008-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Prolactin
LH
FSH
Testosterone
Estradiol

Secondary Outcome Measures

Name	Time	Method
PANSS
HAM-D
Simpson Angus Scale (SAS)

Trial Locations

Locations (1)

University of Bonn, Department of Psychiatry; 🇩🇪 Bonn, Northrhine-Westfalia, Germany