UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014976 |
|---|---|
| Receipt number | R000017430 |
| Scientific Title | Model-Guided Antipsychotic Dose Reduction in Schizophrenia: A Single-Blind Randomized Controlled Trial |
| Date of disclosure of the study information | 2014/08/28 |
| Last modified on | 2020/03/01 09:07:14 |
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Basic information
Public title
Model-Guided Antipsychotic Dose Reduction in Schizophrenia: A Single-Blind Randomized Controlled Trial
Acronym
Model-Guided Antipsychotic Dose Reduction in Schizophrenia: A Single-Blind Randomized Controlled Trial
Scientific Title
Model-Guided Antipsychotic Dose Reduction in Schizophrenia: A Single-Blind Randomized Controlled Trial
Scientific Title:Acronym
Model-Guided Antipsychotic Dose Reduction in Schizophrenia: A Single-Blind Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to test the effectiveness of the model-guided antipsychotic dose reduction in clinically stable patients with schizophrenia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of successful completers
Key secondary outcomes
Positive and Negative Syndrome Scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The dose will be reduced to an individually estimated target dose that correspond to 65% dopamine D2 receptor blockade at trough.
Interventions/Control_2
The dose will be maintained throughout the study period.
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) DSM-IV and DSM5 diagnosis of schizophrenia
(2) Having received a stable dose of risperidone or olanzapine for the previous 3 months
(3) 18 years-old or older and being capable of providing informed consent
Key exclusion criteria
(1) Concomitant use of antipsychotic drugs other than quetiapine at 50 mg or less or its chlorpromazine equivalent at bedtime
(2) History of treatment with long-acting risperidone within 6 months
(3) Active suicidal ideations or past suicide attempts
(4) Presence of severe physical condition, mental retardation, or active substance abuse
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Uchida |
Organization
Minamihanno Hospital
Division name
Department of Psychiatry
Zip code
Address
415 Yaoroshi, Hanno, Saitama
TEL
042-972-7111
hiroyuki.uchida.hu@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Uchida |
Organization
Minamihanno Hospital
Division name
Department of Psychiatry
Zip code
Address
415 Yaoroshi, Hanno, Saitama
TEL
042-972-7111
Homepage URL
hiroyuki.uchida.hu@gmail.com
Sponsor or person
Institute
Minamihanno Hospital
Institute
Department
Personal name
Funding Source
Organization
Takeda Science Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
南飯能病院（埼玉県）、恩方病院（東京都）、大泉病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 28 | 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
Completed
Date of protocol fixation
| 2014 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2014 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2014 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 28 | Day |
Last modified on
| 2020 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017430
