UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037282 |
|---|---|
| Receipt number | R000042506 |
| Scientific Title | Dose Reduction of Long-Acting Injectable Second-Generation Antipsychotics in Stable Schizophrenia: A Multicenter, Double-Blind, Randomized Controlled Trial |
| Date of disclosure of the study information | 2019/07/05 |
| Last modified on | 2024/07/09 10:29:43 |
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Basic information
Public title
A Dose Reduction Trial of Long-Acting Injectable Second-Generation Antipsychotics in Stable Schizophrenia
Acronym
A Dose Reduction Trial of Long-Acting Injectable Second-Generation Antipsychotics in Stable Schizophrenia
Scientific Title
Dose Reduction of Long-Acting Injectable Second-Generation Antipsychotics in Stable Schizophrenia: A Multicenter, Double-Blind, Randomized Controlled Trial
Scientific Title:Acronym
Dose Reduction of Long-Acting Injectable Second-Generation Antipsychotics in Stable Schizophrenia: A Multicenter, Double-Blind, Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Schizophrenia, Schizoaffective disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of dose reduction of LAI-SGAs by 50% or to minimum effective doses on relapse, neurocognition, subjective experiences, and functioning in stable patients with schizophrenia receiving LAI-risperidone or LAI-paliperidone
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in Brief Assessment of Cognition in Schizophrenia (BACS) composite scores from week 0 to week 24
Key secondary outcomes
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
YES
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
Each of the LAI-SGAs 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 (i.e., 25 mg/2 weeks for LAI-risperidone LAI and 50 mg/4 weeks for LAI- paliperidone).
Interventions/Control_2
Each of the LAI-SGAs 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 LAI-risperidone >25 mg/2 weeks or LAI-paliperidone >50 mg/4 weeks 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 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
200
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
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL
03-5363-3829
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, 160-8582, Japan
TEL
03-5363-3829
Homepage URL
hirotak@dk9.so-net.ne.jp
Sponsor or person
Institute
Keio University School of Medicine
Department of Neuropsychiatry
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Ministry of Education, Culture, Sports, Science and Technology
Novartis Pharma K.K.
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-5363-3503
med-rinri-jimu@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）、福岡大学病院（福岡県）、関西医科大学総合医療センター（大阪府）、関西医科大学附属病院（大阪府）、杏林大学医学部附属病院（東京都）、井之頭病院（東京都）、福島県立医科大学附属病院（福島県）、星総合病院附属星ヶ丘病院（福島県）、弘前大学医学部附属病院（青森県）、山梨県立北病院（山梨県）、大泉病院（東京都）、大泉メンタルクリニック（東京都）、あさか台メンタルクリニック（埼玉県）、駒木野病院（東京都）、南ヶ丘病院（福岡県）、下総精神医療センター（千葉県）、あさかホスピタル（福島県）、鶴が丘ガーデンホスピタル（東京都）、セフィロト病院（滋賀県）、琉球大学病院（沖縄県）、南飯能病院（埼玉県）、恩方病院（東京都）、琉球病院（沖縄県）、関西記念病院（大阪府）、桜ヶ丘記念病院（東京都）、東京女子医科大学病院（東京都）、北里大学病院（神奈川県）、聖マリアンナ医科大学病院（神奈川県）、草津病院（広島県）、長谷川病院（東京都）、あさひの丘病院（神奈川県）、桶狭間病院藤田こころケアセンター（愛知県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 13 | 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
| 2019 | Year | 07 | Month | 05 | Day |
Last modified on
| 2024 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042506
