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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000047785
Receipt No. R000054333
Scientific Title Halved dose of antipsychotics versus symptomatic treatment for relapse in patients with schizophrenia receiving high dose antipsychotic therapy: a randomized single blind trial
Date of disclosure of the study information 2022/05/18
Last modified on 2022/05/18

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Basic information
Public title A randomized single-blind trial of the therapeutic effects and safety of halved dose antipsychotics for treating relapse in patients with schizophrenia receiving high dose antipsychotic therapy
Acronym halved dose antipsychotic therapy
Scientific Title Halved dose of antipsychotics versus symptomatic treatment for relapse in patients with schizophrenia receiving high dose antipsychotic therapy: a randomized single blind trial
Scientific Title:Acronym halved dose antipsychotic therapy
Region
Japan

Condition
Condition schizophrenia
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the therapeutic effects and safety of halved dose antipsychotic for treating relapse in patients with schizophrenia receiving high dose antipsychotic therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the period from occurrence of relapse until relapse symptom improvement
Key secondary outcomes Psychiatric symptoms will be evaluated according to the Positive and Negative Syndrome Scale (PANSS), and extrapyramidal symptoms (EPS) according to the Drug-induced Extra-pyramidal Symptoms Scale (DIEPSS) at baseline, at relapse, and after remission. All adverse events that appear will be evaluated.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Halve the amount of antipsychotics in patients receiving high-dose antipsychotics. If relapse is determined, the antipsychotic dose will be reduced.
Interventions/Control_2 treatment with symptomatic treatment
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
70 years-old >=
Gender Male and Female
Key inclusion criteria Patients with schizophrenia receiving high-dose antipsychotic therapy
Key exclusion criteria intellectual disability, neurodevelopmental disorders, organic, including symptomatic, mental disorder, long term depot antipsychotics within 3 months, electroconvulsive therapy within 6 months
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Ryota
Middle name
Last name Ataniya
Organization Edogawa hospital
Division name Department of Psychiatry
Zip code 135-0061
Address 2702, Yamazaki, Noda-shi, Chiba
TEL 4-7124-5511
Email ryotaataniya@pbt.nir.jp

Public contact
Name of contact person
1st name Ryota
Middle name
Last name Ataniya
Organization Edogawa hospital
Division name Department of Psychiatry
Zip code 278-0022
Address 2702, Yamazaki, Noda-shi, Chiba
TEL 4-7124-5511
Homepage URL
Email ryotaataniya@pbt.nir.jp

Sponsor
Institute Showa University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Showa University Institutional Review Board
Address 6-11-11 Kitakarasuyama, Setagaya-ku, Tokyo
Tel 03-3784-8305
Email dh-ctrial@ofc.showa-u.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

Other administrative information
Date of disclosure of the study information
2022 Year 05 Month 18 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 54
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
2020 Year 12 Month 07 Day
Date of IRB
2020 Year 12 Month 21 Day
Anticipated trial start date
2021 Year 01 Month 04 Day
Last follow-up date
2022 Year 01 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
2022 Year 05 Month 18 Day
Last modified on
2022 Year 05 Month 18 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054333

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2022/06/13 data repository.xlsx


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