Schizophrenia
Conditions
Interventions
The dose of aripiprazole will be reduced by 50% of the baseline dose and maintained at this dose for 52 weeks. For safety reasons, the dose will not be reduced beyond the minimum effective dose (9 mg/
Sponsors
Keio University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Outpatients having a diagnose of schizophrenia or schizoaffective disorder according to ICD-10 (2) Aged >= 18 years old (3) Having regularly and consecutively received oral aripiprazole >9 mg/day at the same dose for at least 6 months as antipsychotic monotherapy (4) Not having concomitantly received antipsychotics other than aripiprazole for more than 3 months. However, the concomitant use of quetiapine, chlorpromazine, or levomepromazine at a maximum dose of 50 mg/day at bedtime is allowed. (5) Having been in the remission of positive symptoms defined as a score of <=3 on all of the following 5 PANSS items: delusion (item P1), unusual thought content (item G9), hallucinatory behavior (item P3), conceptual disorganization (item P2), and mannerisms and posturing (item G5) (6) Having provided written informed consent
Exclusion criteria
Exclusion criteria: (1) Having a history of obvious harm to him/herself and/or others (2) Having significant physical or neurological illnesses (3) Having a diagnose of mental and behavioral disorders due to psychoactive substance use according to ICD-10 (4) Being pregnant or lactating (5) Having been judged as unable to provide informed consent by a person who explains the study (6) Being prohibited to receive reimbursement (in cases such as receiving public assistance and being prohibited from receiving reimbursement by the public assistance case worker) (7) Having been judged as unsuitable for the study for other reasons by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in composite score on Brief Assessment of Cognition in Schizophrenia (BACS) from 0 week to 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Relapse rate and time to relapse (2) Study discontinuation rate and time to study discontiuation (3) Psychiatric symptoms, cognitive function, social function, subjective experience and adverse effects * The following are administered at 0, 12, 24, and 52 weeks, unless otherwise noted. - Positive and Negative Syndrome Scale (PANSS) - Brief Evaluation of Psychosis Symptom Domains - Version 2.0 (BE-PSD-V2.0) - Clinical Global Impression-Severity Scale (CGI-S) - Japanese Adult Reading Test (JART) (at 0 week) - Personal and Social Performance Scale (PSP) - Subjective Well-being under Neuroleptics Scale - Short form (SWNS) - Japanese version of the Perceived Deficits Questionnaire (PDQ) - Visual Analogue Scale for Distress Associated with Symptoms (VAS-DAS) - Visual Analogue Scale for Distress Associated with Side Effects (VAS-DASE) - Evaluation of Antipsychotic Side Effects (EASE) - Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) - Barnes Akathisia Rating Scale (BARS) - Subjective Akathisia Rating Scale (SARS) - Autonomic side effects of UKU side effect rating scale - Clinical Global Impression Scale - Side Effects (CGI-SE) (4) Weight and blood biochemical tests - Body weight - Blood biochemical tests: triglycerides, LDL cholesterol, HDL cholesterol, fasting blood glucose, serum prolactin level (at 0 and 24 weeks) (5) Blood levels of antipsychotic drugs - Blood concentrations of aripiprazole and its active metabolite (dehydro-aripiprazole) (6) Medication Possession Ration (MPR) | — |
Countries
Japan
Contacts
Public ContactHiroyoshi Takeuchi
Keio University School of Medicine Department of Neuropsychiatry
Outcome results
None listed