UMIN-CTR Clinical Trial

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

schizophrenia

Classification by specialty

Psychosomatic Internal Medicine

Classification by malignancy

Others

Genomic information

NO

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

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).

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

The Japanese Society of Psychiatric Pharmacy

Institute

Department

Personal name

Organization

The Japanese Society of Psychiatric Pharmacy

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2021

Year

07

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2021

Year

06

Month

28

Day

Last modified on

2021

Year

06

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043326