Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
The Monitor of Serum Prolactin Level in a 3 Months Aripiprazole Trial
This study is currently recruiting participants.
Verified by Yu-Li Hospital, April 2007
Sponsored by: Yu-Li Hospital
Information provided by: Yu-Li Hospital
ClinicalTrials.gov Identifier: NCT00468533
  Purpose

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


Condition Intervention Phase
Schizophrenia, Tardive Dyskinesia, Metabolic Syndrome
Drug: Aripiprazole
Phase IV

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia
MedlinePlus related topics: Schizophrenia
Drug Information available for: Aripiprazole Prolactin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title: The Monitor of Serum Prolactin Level and Related Clinical Observations Among Individuals With Schizophrenia Spectrum Illnesses in a 3 Months Aripiprazole Trial

Further study details as provided by Yu-Li Hospital:

Primary Outcome Measures:
  • prolactin level drops after shifting to aripiprazole [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • correlations between prolactin and other clinical outcomes [ Time Frame: 6 months ]

Estimated Enrollment: 50
Study Start Date: May 2006
Estimated Study Completion Date: July 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients may be included in the study if they meet the following criteria:

  1. Males and females 16-65 years of age
  2. Diagnosis of schizophrenia, schizoaffective or schizophreniform disorder
  3. Each individual must have a level of understanding sufficient to perform all tests and examinations required
  4. Individuals must be willing to fast after midnight the evening prior to study visit
  5. Individuals must be willing to provide a small sample of blood for evaluation
  6. Individuals must be willing to participate in a short 30-45 minute clinical interview

Exclusion Criteria:

Patients may be excluded from the study for any of the following reasons:

  1. A current diagnosis of diabetes mellitus
  2. Serious unstable illness such that death is anticipated within 1 year or intensive care unit hospitalization for the condition is anticipated within 6 months
  3. Uncorrected hypothyroidism or hyperthyroidism
  4. Uncorrected tumor secreting ectopic prolactinemia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00468533

Contacts
Contact: Tsuo-Hung Lan, MD, PhD 886-3-8886141 ext 2221 tosafish@gmail.com

Locations
Taiwan
Yu-Li Hospital, DOH Recruiting
Hualien, Taiwan, 981
Contact: Hsien-Jane Chiu, MD, MPH, PhD     03-8886141 ext 2220     ylh.ebmc@gmail.com    
Principal Investigator: Tsuo-Hung Lan, MD, PhD            
Sponsors and Collaborators
Yu-Li Hospital
Investigators
Principal Investigator: Tsuo-Hung Lan, MD, PhD Yu-Li Hospital
  More Information

Study ID Numbers: YLH-IRB-9506
Study First Received: April 30, 2007
Last Updated: April 30, 2007
ClinicalTrials.gov Identifier: NCT00468533  
Health Authority: Taiwan: Department of Health

Keywords provided by Yu-Li Hospital:
Arupiprazole, prolacin, PANSS, CGI, AIMS

Study placed in the following topic categories:
Schizophrenia
Signs and Symptoms
Mental Disorders
Movement Disorders
Neurologic Manifestations
Central Nervous System Diseases
Psychotic Disorders
Aripiprazole
Dyskinesias
Tardive dyskinesia
Schizophrenia and Disorders with Psychotic Features
Oral facial dyskinesia

Additional relevant MeSH terms:
Tranquilizing Agents
Pathologic Processes
Disease
Therapeutic Uses
Syndrome
Physiological Effects of Drugs
Nervous System Diseases
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009