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

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ClinicalTrials.gov Identifier: NCT00468533
Recruitment Status : Unknown
Verified April 2007 by Yu-Li Hospital.
Recruitment status was:  Recruiting
First Posted : May 2, 2007
Last Update Posted : May 2, 2007
Sponsor:
Information provided by:
Yu-Li Hospital

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.

Condition or disease Intervention/treatment Phase
Schizophrenia, Tardive Dyskinesia, Metabolic Syndrome Drug: Aripiprazole Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2006
Estimated Study Completion Date : July 2007





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

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


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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00468533     History of Changes
Other Study ID Numbers: YLH-IRB-9506
First Posted: May 2, 2007    Key Record Dates
Last Update Posted: May 2, 2007
Last Verified: April 2007

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

Additional relevant MeSH terms:
Schizophrenia
Metabolic Syndrome X
Dyskinesias
Tardive Dyskinesia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Dyskinesia, Drug-Induced
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs