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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Yu-Li Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Yu-Li Hospital
ClinicalTrials.gov Identifier:
NCT00468533
First received: April 30, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Monitor of Serum Prolactin Level and Related Clinical Observations Among Individuals With Schizophrenia Spectrum Illnesses in a 3 Months Aripiprazole Trial

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

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

Additional relevant MeSH terms:
Dyskinesias
Schizophrenia
Movement Disorders
Metabolic Syndrome X
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 26, 2014