Risperidone-Induced Hyperprolactinemia Treated With Bromocriptine

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Brief Title

Risperidone-Induced Hyperprolactinemia Treated With Bromocriptine

Official Title

Therapy With Bromocriptine in Patients With Symptomatic Risperidone-Induced Hyperprolactinemia

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 Phase

Phase 3

Study Type

Interventional

Primary Outcome

Prolactin

Secondary Outcome

 PANSS

Condition

Schizophrenia

Intervention

Bromocriptin

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

20

Start Date

May 2006

Completion Date

May 2008

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

Gender

Male

Ages

18 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

Wolfgang Maier, MD, 0049-(0)228-287-5681, [email protected]

Location Countries

Germany

Location Countries

Germany

Administrative Informations

NCT ID

NCT00315081

Organization ID

150-05

Study Sponsor

University Hospital, Bonn

Study Sponsor

Wolfgang Maier, MD, Principal Investigator, University of Bonn, Department of Psychiatry

Verification Date

November 2005