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Improving Cognitive Function of Aripiprazole in Treating Adolescents and Young Adults With Psychotic Disorder

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2007 by Genovate Biotechnology Co., Ltd.,.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00541502
First Posted: October 10, 2007
Last Update Posted: October 10, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by:
Genovate Biotechnology Co., Ltd.,
  Purpose
This is a 24-week, observational, prospective study to evaluate the effectiveness of improving cognitive function of aripiprazole in treating adolescents and young adults with psychotic disorder in Taiwan. Approximately 120 qualified patients who have clinical diagnosis of DSM-IV of psychotic symptom (e.g. schizophrenia or other psychotic disorders such as schizophreniform disorder, schizoaffective disorder, delusional disorder, shared psychotic disorder, bipolar disorder with psychotic feature or psychotic disorder not otherwise specified.) will be recruited to achieve at least 100 evaluable subjects. After signing the informed consent form, the demographics, medical history and concomitant medication will be recorded. Besides, physical examination, vital sign, BMI, DSM-IV multiaxial examination, CGI-S and menstrual history will be conducted. Laboratory tests and pregnancy test will be optionally conducted. After evaluating all variables obtained, the eligible patients will be enrolled into study. Patients who fulfill the inclusion / exclusion criteria will be performed the CPT, WCST, BPRS and WHOQOL. Afterwards, patients will be given their first medication at this visit (5 mg ~ 30 mg daily by subject). Besides, the switching period is maximum 8 weeks and is depended upon the clinical judgment of investigator. Efficacy will be evaluated by the change from baseline in Continuous Performance Test (CPT), Wisconsin Card Sorting Test (WCST), Clinical Global Impression Scale (CGI), Brief Psychiatric Rating Scale (BPRS) and The World Health Organization Quality of Life questionnaire (WHOQOL). Safety will be evaluated by the frequency of adverse events, abnormal laboratory results, physical examination, vital sign, BMI and menstrual history for female subgroup analysis.

Condition
Psychotic Disorders

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Obervational, Prospective Study to Evaluate the Effectiveness of Improving Cognitive Function of Aripiprazole in Treating Adolescents and Young Adults With Psychotic Disorder in Taiwan

Resource links provided by NLM:


Further study details as provided by Genovate Biotechnology Co., Ltd.,:

Study Start Date: November 2007
Estimated Study Completion Date: October 2008
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  1. Male or female in age between 12 and 25 years old.
  2. Clinical diagnosis of DSM-IV of psychotic symptom (e.g. schizophrenia or other psychotic disorders such as schizophreniform disorder, schizoaffective disorder, delusional disorder, shared psychotic disorder, bipolar disorder with psychotic feature or psychotic disorder not otherwise specified.).
  3. CGI-S ≧ 3 at screening visit.
  4. Informed Consent was obtained from the subject (and legal guardian as if necessary).

Exclusion Criteria:

  1. Pregnant or breast feeding women or planning a pregnancy.
  2. Patient received electroconvulsive therapy within 4 weeks before the screening visit.
  3. Patient has a history of hypersensitivity or allergy to investigated drug.
  4. A known severe adverse event related to any antipsychotic medication (including but not limited to haloperidol, chlorpromazine, thioridazine, pimozide, risperidone, quetiapine, ziprasidone).
  5. Any clinical condition or significant concurrent disease judged by the investigator to complicate the evaluation of the study treatment.
  Contacts and Locations
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): NCT00541502


Sponsors and Collaborators
Genovate Biotechnology Co., Ltd.,
Otsuka Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Chen Chih-Ken, PhD Chang Gung Memorial Hospital, Keelung, Taiwan
  More Information

ClinicalTrials.gov Identifier: NCT00541502     History of Changes
Other Study ID Numbers: 31-06-P04
First Submitted: October 8, 2007
First Posted: October 10, 2007
Last Update Posted: October 10, 2007
Last Verified: October 2007

Keywords provided by Genovate Biotechnology Co., Ltd.,:
evaluate the effectiveness of improving cognitive function of aripiprazole in treating adolescents and young adults with psychotic disorder in Taiwan

Additional relevant MeSH terms:
Disease
Mental Disorders
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs


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