UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051193 |
|---|---|
| Receipt number | R000058177 |
| Scientific Title | Aripiprazole dose reduction in stable schizophrenia |
| Date of disclosure of the study information | 2023/05/30 |
| Last modified on | 2025/01/18 16:16:51 |
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Basic information
Public title
Aripiprazole dose reduction in stable schizophrenia
Acronym
Aripiprazole dose reduction in stable schizophrenia
Scientific Title
Aripiprazole dose reduction in stable schizophrenia
Scientific Title:Acronym
Aripiprazole dose reduction in stable schizophrenia
Region
| Japan |
Condition
Condition
Schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Antipsychotics not only improve psychiatric symptoms in the acute phase of schizophrenia, but also prevent relapse in stabilized patients. On the other hand, antipsychotics can induce adverse effects, including extrapyramidal symptoms and metabolic and cardiovascular disturbances, in a dose-dependent fashion. Thus, treatment with antipsychotics at the lowest possible dose is needed. Meta-analyses have shown that reducing antipsychotics to the minimum effective dose improve negative symptoms, cognitive functions, and extrapyramidal symptoms without increasing relapse.
However, no studies on dose reduction of aripiprazole have been conducted. Therefore, we will evaluate the effects of dose reduction of aripiprazole by 50% or to the minimum effective dose on relapse and adverse effects in a 52-week, double-blind randomized controlled trial (RCT) involving patients in the maintenance phase of schizophrenia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in composite score on Brief Assessment of Cognition in Schizophrenia (BACS) from 0 week to 24 weeks
Key secondary outcomes
(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)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
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/day).
Interventions/Control_2
The dose of aripiprazole will be maintained at the baseline dose for 52 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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
Key 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
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroyoshi |
| Middle name | |
| Last name | Takeuchi |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
Shinanomachi 35, Shinjuku-ku, Tokyo
TEL
03-3353-1211
hirotak@dk9.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Hiroyoshi |
| Middle name | |
| Last name | Takeuchi |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
hirotak@dk9.so-net.ne.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Hiroyoshi Takeuchi
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-3353-1211
med-rinri-ft_pt@adst.keio.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
慶應義塾大学病院（東京都）、駒木野病院（東京都）、大泉病院（東京都）、桜ヶ丘記念病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 04 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 03 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 29 | Day |
Last modified on
| 2025 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058177
