Case-series study for the development of drug/dose-reduction guidelines for antipsychotics

Case-series study for the development of drug/dose-reduction guidelines for antipsychotics - Case-series study for the development of drug/dose-reduction guidelines for antipsychotics

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000044689

Enrollment

200

Registered

2021-07-01

Start date

2021-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

schizophrenia

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Patients judged by a physician to be inappropriate as a participant

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Secondary

Measure	Time frame
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).	—

Countries

Japan

Contacts

Public ContactHiroyuki Kamei

Meijo University Faculty of Pharmacy

hkamei@meijo-u.ac.jp+81-52-839-2643

Outcome results