UMIN-CTR Clinical Trial

Basic information
Public title	The effectiveness and prognosis of several treatment options for treatment-resistant schizophrenia: An observational study
Acronym	The effectiveness and prognosis of several treatment options for treatment-resistant schizophrenia: An observational study
Scientific Title	The effectiveness and prognosis of several treatment options for treatment-resistant schizophrenia: An observational study
Scientific Title:Acronym	The effectiveness and prognosis of several treatment options for treatment-resistant schizophrenia: An observational study
Region	Japan

Condition
Condition	Schizophrenia, Schizoaffective disorder
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Comparison of effectiveness over a medium term (approx. 2 years) of the following treatment options for refractory patients with schizophrenia or schizoaffective disorder: clozapine, long-acting injectable forms of atypical antipsychotic, oral atypical antipsychotics with long half-lives, dopamine partial agonist, and electroconvulsive therapy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Percent change of Brief Psychiatric Rating Scale (BPRS) score from pre-treatment to post-treatment with the indexed treatment option
Key secondary outcomes	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

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	65 years-old >=
Gender	Male and Female
Key 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
Key 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
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masaomi Iyo
Organization	Chiba University Graduate School of Medicine
Division name	Department of Psychiatry
Zip code
Address	1-8-1 Inohana, Chuou-ku, Chiba City, Chiba, Japan
TEL	043-222-7171
Email	iyom@faculty.chiba-u.jp

Public contact
Name of contact person	1st name Middle name Last name Nobuhisa Kanahara
Organization	Chiba University Center for Forensic Mental Health
Division name	Division of Medical Treatment and Rehabilitation
Zip code
Address	1-8-1 Inohana, Chuou-ku, Chiba City, Chiba, Japan
TEL	043-222-7171
Homepage URL
Email	kanahara@faculty.chiba-u.jp

Sponsor
Institute	Department of Psychiatry, Chiba University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	同和会千葉病院（千葉県）、千葉県精神科医療センター（千葉県）、さつき会袖ヶ浦さつき台病院（千葉県）、 同仁会木更津病院（千葉県）、学而会木村病院（千葉県）、国保旭中央病院（千葉県）、成田赤十字病院（千葉県）、千葉市立青葉病院（千葉県）、白百合会市原鶴岡病院（千葉県）、市ヶ谷ひもろぎクリニック（東京都）、ホヅミクリニック（東京都）、南湖こころのクリニック（福島県）

Other administrative information
Date of disclosure of the study information	2017 Year 03 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	No longer recruiting
Date of protocol fixation	2017 Year 02 Month 01 Day
Date of IRB	2017 Year 02 Month 01 Day
Anticipated trial start date	2017 Year 03 Month 01 Day
Last follow-up date	2020 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Comparison of effectiveness over a medium term (approx. 2 years) of the following treatment options for refractory patients with schizophrenia or schizoaffective disorder: clozapine, long-acting injectable forms of atypical antipsychotic, oral atypical antipsychotics with long half-lives, dopamine partial agonist, and electroconvulsive therapy

Management information
Registered date	2017 Year 02 Month 21 Day
Last modified on	2019 Year 08 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029969