UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037946 |
|---|---|
| Receipt number | R000041477 |
| Scientific Title | Impact of switching to single dosing regimen of antipsychotics on medication adherence in schizophrenia: A randomized controlled trial |
| Date of disclosure of the study information | 2019/09/06 |
| Last modified on | 2024/09/17 22:57:49 |
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Basic information
Public title
Impact of switching to single dosing regimen of antipsychotics on medication adherence in schizophrenia: A randomized controlled trial
Acronym
Impact of switching to single dosing regimen of antipsychotics on medication adherence in schizophrenia: A randomized controlled trial
Scientific Title
Impact of switching to single dosing regimen of antipsychotics on medication adherence in schizophrenia: A randomized controlled trial
Scientific Title:Acronym
Impact of switching to single dosing regimen of antipsychotics on medication adherence in schizophrenia: A randomized controlled trial
Region
| Japan |
Condition
Condition
Schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To improve medication adherence in schizophrenia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Medication adherence at 12 weeks after intervention
Key secondary outcomes
Positive and Negative Syndrome Scale (PANSS); Brief Evaluation of Psychosis Symptom Domains (BE-PSD); Clinical Global Impression - Global Severity (CGI-S); Brief Assessment of Cognition in Schizophrenia (BACS); Personal and Social Performance Scale (PSP); Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS); UKU Side Effect Rating Scale (UKU-SERS); Subjective well-being under neuroleptic drug treatment short form (SWNS); Perceived Deficits Questionnaire (PDQ); Visual Analogue Scale for Distress Associated with Symptoms (VAS-DAS); blood sampling for general test, plasma assay at start and 12 weeks after intervention
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
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Switching multiple daily dosing regimen of antipsychotics to single dosing regimen
Interventions/Control_2
Continuing multiple daily dosing regimen of antipsychotics
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Japanese outpatient without admission for recent at least 3 months
(2) Being diagnosed with schizophrenia according to ICD-10
(3) Receiving oral antipsychotics twice or more a day without any change in type, dose, or dosing regimen of antipsychotics for at least 3 months, and not receiving long-acting injectable antipsychotics
(4) Not lower than 20 years old
(5) Being capable to provide informed consent
Key exclusion criteria
(1) Having serious medical conditions
(2) Having a history of mental and behavioral disorders due to psychoactive substance use
(3) Being pregnant or lactating
(4) Being incapable to understand Japanese language
(5) Having a history of blood sampling-induced vasovagal reaction
(6) Being judged as inappropriate by investigators
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroyoshi |
| Middle name | |
| Last name | Takeuchi |
Organization
Yamanashi Prefectural Kita Hospital
Division name
Department of psychiatry
Zip code
407-0046
Address
3314-13 Minamiwari, Kamijyo, Asahi-machi, Nirasaki-shi, Yamanashi, 407-0046, Japan
TEL
0551-22-1621
hirotak@dk9.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Hodaka |
| Middle name | |
| Last name | Yaegashi |
Organization
Yamanashi Prefectural Kita Hospital
Division name
Department of psychiatry
Zip code
407-0046
Address
3314-13 Minamiwari, Kamijyo, Asahi-machi, Nirasaki-shi, Yamanashi, 407-0046, Japan
TEL
0551-22-1621
Homepage URL
h.yaemon@hotmail.co.jp
Sponsor or person
Institute
Yamanashi Prefectural Kita Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Yamanashi Prefectural Central Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Yamanashi Prefectural Kita Hospital
Address
3314-13 Minamiwari, Kamijyo, Asahi-machi, Nirasaki-shi, Yamanashi, 407-0046, Japan
Tel
0551-22-1621
yazaki-abtc@ych.pref.yamanashi.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
山梨県立北病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 06 | 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
Suspended
Date of protocol fixation
| 2019 | Year | 08 | Month | 02 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 06 | Day |
Last follow-up date
| 2024 | 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 | 09 | Month | 06 | Day |
Last modified on
| 2024 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041477
