The effectiveness and prognosis of several treatment options for treatment-resistant schizophrenia: An observational study

The effectiveness and prognosis of several treatment options for treatment-resistant schizophrenia: An observational study - The effectiveness and prognosis of several treatment options for treatment-resistant schizophrenia: An observational study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000026241

Enrollment

300

Registered

2017-03-01

Start date

2017-03-01

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, Schizoaffective disorder

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Having a diagnosis of schizophrenia or schizoaffective disorder according to DSM-5 (American Psychiatric Association) 2. Within age range from 16 to 65 years old at the attainment of informed consent 3. Not achieving a score >40 points on average on the GAF within 1 year prior to the study screening 4. Meeting the criteria for treatment-resistant schizophrenia 5. The patient has been informed of the diagnosis of schizophrenia or schizoaffective disorder 6. Japanese ethnicity

Exclusion criteria

Exclusion criteria: 1. Under clozapine treatment 2. The patient has not been informed of the diagnosis 3. Refusing treatment for his/her schizophrenia or schizoaffective disorder 4. A history of head trauma injury accompanied by loss of consciousness 5. Having a diagnosis or a suspected diagnosis of a central nervous disease such as epilepsy, inflammatory disorder, degenerative disorder or cerebrovascular disease 6. Under a distressing physical condition due to severe physical disease such as heart, respiratory, intestinal or renal disease 7. Having a diagnosis or a suspected diagnosis of cancer 8. Pregnant or suspected of being pregnant 9. Lactating 10. Judged by his/her physician to be inappropriate to participate in the study for any reason other than reasons 1-9

Design outcomes

Primary

Measure	Time frame
Percent change of Brief Psychiatric Rating Scale (BPRS) score from pre-treatment to post-treatment with the indexed treatment option	—

Secondary

Measure	Time frame
1. Percent change of BPRS from baseline to the study's endpoint of follow-up at 24 months 2. Percent change of Global Assessment of Functioning (GAF) from baseline to the study's endpoint of follow-up at 24 months 3. Clinical Global Impression-Change (CGI-C) at the study's endpoint at 24 months 4. Antipsychotics dose (chlorpromazine-equivalent dose) change from baseline to the study's endpoint at 24 months 5. Subjective symptoms reported by the patients 6. Percent change of Drug-induced Extra-pyramidal Symptoms Scale (DIEPSS) score from baseline to the study's endpoint at 24 months	—

Measure

Time frame

1. Percent change of BPRS from baseline to the study's endpoint of follow-up at 24 months 2. Percent change of Global Assessment of Functioning (GAF) from baseline to the study's endpoint of follow-up at 24 months 3. Clinical Global Impression-Change (CGI-C) at the study's endpoint at 24 months 4. Antipsychotics dose (chlorpromazine-equivalent dose) change from baseline to the study's endpoint at 24 months 5. Subjective symptoms reported by the patients 6. Percent change of Drug-induced Extra-pyramidal Symptoms Scale (DIEPSS) score from baseline to the study's endpoint at 24 months

—

Countries

Japan

Contacts

Public ContactNobuhisa Kanahara

Chiba University Center for Forensic Mental Health Division of Medical Treatment and Rehabilitation

kanahara@faculty.chiba-u.jp043-222-7171

Outcome results