Risperidone-Induced Hyperprolactinemia Treated With Bromocriptine

Schizophrenia Clinical Trial

Official title:

Therapy With Bromocriptine in Patients With Symptomatic Risperidone-Induced Hyperprolactinemia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00315081
• Other study ID #: 150-05
• Status: Not yet recruiting
• Phase: Phase 3
• First received: April 13, 2006
• Last updated: April 13, 2006
• Start date: May 2006
• Est. completion date: May 2008

Study information

• Verified date: November 2005
• Source: University Hospital, Bonn
• Contact: Kai-Uwe Kuehn, MD
• Phone: 0049-(0)228-287-5681
• Email: kai-uwe.kuehn[@]ukb.uni-bonn.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: May 2008
• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperprolactinemia
• Schizophrenia

Intervention

Drug:
• Bromocriptin

Locations

Country	Name	City	State
Germany	University of Bonn, Department of Psychiatry	Bonn	Northrhine-Westfalia

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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

Outcome

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)