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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00315081
Other study ID # 150-05
Secondary ID
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
Est. primary completion date
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


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)
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