NCT00315081

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_3 schizophrenia

Timeline
Completed

Started May 2006

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 17, 2006

Completed
14 days until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

April 17, 2006

Status Verified

November 1, 2005

First QC Date

April 13, 2006

Last Update Submit

April 13, 2006

Conditions

SchizophreniaHyperprolactinemia

Keywords

SchizophreniaHyperprolactinemiaRisperidoneBromocriptin

Outcome Measures

Primary Outcomes (5)

  • Prolactin

  • LH

  • FSH

  • Testosterone

  • Estradiol

Secondary Outcomes (3)

  • PANSS

  • HAM-D

  • Simpson Angus Scale (SAS)

Interventions

BromocriptinDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • Severe somatic disease, especially coronary disease.
  • Acute psychotic exacerbation.
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bonn, Department of Psychiatry

Bonn, Northrhine-Westfalia, 53105, Germany

Location

Related Publications (1)

  • 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.

    PMID: 15467977BACKGROUND

MeSH Terms

Conditions

SchizophreniaHyperprolactinemia

Interventions

Bromocriptine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersHyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ErgotaminesErgot AlkaloidsAlkaloidsHeterocyclic CompoundsErgolinesHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-Ring

Study Officials

  • Wolfgang Maier, MD

    University of Bonn, Department of Psychiatry

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kai-Uwe Kuehn, MD

CONTACT

0049-(0)228-287-5681kai-uwe.kuehn@ukb.uni-bonn.de

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 13, 2006

First Posted

April 17, 2006

Study Start

May 1, 2006

Study Completion

May 1, 2008

Last Updated

April 17, 2006

Record last verified: 2005-11

Locations

DE(1)