UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044689
Receipt No. R000043326
Scientific Title Case-series study for the development of drug/dose-reduction guidelines for antipsychotics
Date of disclosure of the study information 2021/07/01
Last modified on 2021/06/28

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Case-series study for the development of drug/dose-reduction guidelines for antipsychotics
Acronym Case-series study for the development of drug/dose-reduction guidelines for antipsychotics
Scientific Title Case-series study for the development of drug/dose-reduction guidelines for antipsychotics
Scientific Title:Acronym Case-series study for the development of drug/dose-reduction guidelines for antipsychotics
Region
Japan

Condition
Condition schizophrenia
Classification by specialty
Psychosomatic Internal Medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 One of the important issues concerning medical therapy for schizophrenia that is characteristic of Japan is the use of multiple antipsychotic drugs in large doses. An international comparison of the number of antipsychotic drugs used showed that a single drug is prescribed in about 80% of patients in the United States but in only about 30% in Japan. The NICE guidelines present insufficient evidence of symptomatic improvements by the administration of multiple antipsychotics, express concern over the increased risk of adverse reactions, and recommend single-drug therapy. Moreover, not only the occurrence of many adverse reactions, such as extrapyramidal symptoms and autonomic symptoms, but also the risk of death due to the use of multiple antipsychotic drugs have been raised as problems. For correcting the use of multiple antipsychotic drugs in large doses, evidence-based drug/dose-reducing guidelines are indispensable, and a dose-reduction protocol based on the SCAP (safety correction of high-dose antipsychotic polypharmacy) method has been proposed. However, the presence of cases that do not adhere to the SCAP method and dose-reduction methods in consideration of the pharmacological characteristics or pharmacokinetics of each antipsychotic drug have not been evaluated. In this study, therefore, we aim to collect cases in which a dose reduction was carried out according to the conventional SCAP method, prepare a case series by accumulating cases that succeeded in dose reduction or conversion to a single-drug regimen and those that did not comply with the SCAP method, and lay the foundation for highly useful dose-reduction methods for individual antipsychotics.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Success or failure of drug/dose reduction of antipsychotic medication
Cases of success: Drug/dose reduction has been accomplished by the SCAP method, and no exacerbation of symptoms has been observed. The degree of symptomatic exacerbation is judged according to the change in Clinical Global Impression (CGI) 1 month after the accomplishment of drug reduction or dose reduction compared with CGI before the beginning of drug reduction or dose reduction.
Cases of failure: Exacerbation of symptoms has been observed despite drug/dose reduction conducted by the SCAP method, or the patient has dropped out of the SCAP method due to exacerbation of symptoms.
Criteria for discontinuation: (1) Retraction of consent by the study participant, (2) Judgment by the physician in charge that continuation of the study is undesirable based on the disease condition or the course of treatment of the study participant. (3) Other situations in which the physician in charge has judged that the study should be discontinued are included. The degree of exacerbation of symptoms is evaluated according to the change in CGI 1 month after the accomplishment of drug reduction or dose reduction or at the time of discontinuation of drug/dose reduction compared with CGI before the beginning of drug/dose reduction.
The study is ended 12 months after participation of the patient, in principle, and, if drug reduction to single-drug therapy is accomplished during this period, evaluation is made 4 weeks after conversion to single-drug therapy.
Key secondary outcomes Reasons for the failure in drug/dose reduction of antipsychotic medication, changes in the dose associated with dose reduction of antipsychotic medication, and DIEPSS (Drug-Induced Extrapyramidal Symptoms Scale) score (assessment of 9 items).

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Inpatients or outpatients with schizophrenia who have taken 2 or more antipsychotic drugs continuously for at least 4 weeks and have shown stabilized psychiatric symptoms
Key exclusion criteria Patients judged by a physician to be inappropriate as a participant
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Hiroyuki
Middle name
Last name Kamei
Organization Meijo University
Division name Faculty of Pharmacy
Zip code 468-8503
Address 150 Yagotoyama, Tempaku-ku, Nagoya, Japan
TEL +81-52-839-2643
Email hkamei@meijo-u.ac.jp

Public contact
Name of contact person
1st name Hiroyuki
Middle name
Last name Kamei
Organization Meijo University
Division name Faculty of Pharmacy
Zip code 468-8503
Address 150 Yagotoyama, Tempaku-ku, Nagoya, Japan
TEL +81-52-839-2643
Homepage URL
Email hkamei@meijo-u.ac.jp

Sponsor
Institute The Japanese Society of Psychiatric Pharmacy
Institute
Department

Funding Source
Organization The Japanese Society of Psychiatric Pharmacy
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 The Japanese Society of Psychiatric Pharmacy
Address Nogisaka Building 3rd floor, 9-6-41 Akasaka, Minato-ku, Tokyo
Tel +81-3-5832-6126
Email contact@js-pp.or.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
2021 Year 07 Month 01 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 Preinitiation
Date of protocol fixation
2019 Year 06 Month 03 Day
Date of IRB
Anticipated trial start date
2021 Year 07 Month 01 Day
Last follow-up date
2026 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The antipsychotic drug/dose-reduction planning sheet is downloaded from the website of the Japanese Society of Psychiatric Pharmacy, clinical information concerning the patients in whom drug/dose-reduction has been attempted is input, and the sheet is uploaded to the same website. A case series is established for each drug intended to be reduced in the accumulated patients. For uploading the patient data to the website of the Japanese Society of Psychiatric Pharmacy, the website is made accessible with the membership number, the uploaded data files are coded by the website manager, and the confidentiality, integrity, and availability of the information are ensured by preventing access by persons other than the manager.

Management information
Registered date
2021 Year 06 Month 28 Day
Last modified on
2021 Year 06 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043326

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.