Status:

UNKNOWN

The Monitor of Serum Prolactin Level in a 3 Months Aripiprazole Trial

Lead Sponsor:

Yu-Li Hospital

Conditions:

Schizophrenia, Tardive Dyskinesia, Metabolic Syndrome

Eligibility:

All Genders

16-65 years

Phase:

PHASE4

Brief Summary

A short term post-market monitoring of serum prolactin level change among patients with schizophrenia shifting from other antispychotics to different dosages of aripiprazole.

Detailed Description

This is an open-label clinical trial of adult inpatients or outpatients with a diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder as measured by the Diagnostic and Stat...

Eligibility Criteria

Inclusion

  • Patients may be included in the study if they meet the following criteria:
  • Males and females 16-65 years of age
  • Diagnosis of schizophrenia, schizoaffective or schizophreniform disorder
  • Each individual must have a level of understanding sufficient to perform all tests and examinations required
  • Individuals must be willing to fast after midnight the evening prior to study visit
  • Individuals must be willing to provide a small sample of blood for evaluation
  • Individuals must be willing to participate in a short 30-45 minute clinical interview

Exclusion

  • Patients may be excluded from the study for any of the following reasons:
  • A current diagnosis of diabetes mellitus
  • Serious unstable illness such that death is anticipated within 1 year or intensive care unit hospitalization for the condition is anticipated within 6 months
  • Uncorrected hypothyroidism or hyperthyroidism
  • Uncorrected tumor secreting ectopic prolactinemia

Key Trial Info

Start Date :

May 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 1 2007

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT00468533

Start Date

May 1 2006

End Date

July 1 2007

Last Update

May 2 2007

Active Locations (1)

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1

Yu-Li Hospital, DOH

Hualien City, Hualien, Taiwan, 981