Clinical trial NCT00541502: Improving Cognitive Function of Aripiprazole in Treating Adolescents and Young Adults With Psychotic Disorder
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Psychotic Disorders
Keywords: evaluate the effectiveness of improving cognitive function of aripiprazole in treating adolescents and young adults with psychotic disorder in Taiwan
Lead sponsor: Genovate Biotechnology Co., Ltd.,
Sponsor class: INDUSTRY
Collaborators: name: Otsuka Pharmaceutical Co., Ltd.
First posted: 2007-10-10
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Time perspective: PROSPECTIVE

Brief 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.


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Chang Gung Memorial Hospital, Keelung, Taiwan
name: Chen Chih-Ken, PhD
role: PRINCIPAL_INVESTIGATOR
References: