Clinical trial NCT00315081: Risperidone-Induced Hyperprolactinemia Treated With Bromocriptine
Official title: Therapy With Bromocriptine in Patients With Symptomatic Risperidone-Induced Hyperprolactinemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Schizophrenia
Hyperprolactinemia
Keywords: Schizophrenia
Hyperprolactinemia
Risperidone
Bromocriptin
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2006-04-17
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Prolactin
measure: LH
measure: FSH
measure: Testosterone
measure: Estradiol
Secondary outcomes:
measure: PANSS
measure: HAM-D
measure: Simpson Angus Scale (SAS)
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University of Bonn, Department of Psychiatry
state: Northrhine-Westfalia
Study officials:
affiliation: University of Bonn, Department of Psychiatry
name: Wolfgang Maier, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bliesener N, Yokusoglu H, Quednow BB, Klingmuller D, Kuhn KU. Usefulness of bromocriptine in the treatment of amisulpride-induced hyperprolactinemia: a case report. Pharmacopsychiatry. 2004 Jul;37(4):189-91. doi: 10.1055/s-2004-827176. No abstract available.