CClinicalTrials.gg
Status unknownNCT00541502Updated Oct 10, 2007

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

An observational study in Psychotic Disorders, sponsored by Genovate Biotechnology Co., Ltd.,. Status unknown. Open to participants aged 12 Years to 25 Years. Per ClinicalTrials.gov, last updated 2007-10-10.

Sponsored by Genovate Biotechnology Co., Ltd., · Observational

The sponsor has not verified this record recently (last verified Oct 2007), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Time perspective
Prospective
Ages
12 Years to 25 Years
Sex
All
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Study summary

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.

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Conditions studied

  • Psychotic Disorders

Keywords

  • evaluate the effectiveness of improving cognitive function of aripiprazole in treating adolescents and young adults with psychotic disorder in Taiwan
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In context

Mental Disorders

2,107 studies on the registry are indexed under Mental Disorders; 416 are open to participants now.

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Lead sponsor

Genovate Biotechnology Co., Ltd., is the lead sponsor of 12 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Years to 25 Years
Sexes eligible
All

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

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.
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Study design

Time perspective
Prospective
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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 10, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00541502
Lead sponsor
Genovate Biotechnology Co., Ltd.,
Collaborators
Otsuka Pharmaceutical Co., Ltd.
First posted
Oct 10, 2007
Start date
Nov 2007
Completion
Oct 2008 (estimated)
Last update
Oct 10, 2007

Study contacts

Chen Chih-Ken, PhD
principal investigator · Chang Gung Memorial Hospital, Keelung, Taiwan

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2007. You cannot join it, but the record below documents what was studied.

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