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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026241
Receipt No. R000029969
Scientific Title The effectiveness and prognosis of several treatment options for treatment-resistant schizophrenia: An observational study
Date of disclosure of the study information 2017/03/01
Last modified on 2018/02/23

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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 Enrolling by invitation
Date of protocol fixation
2017 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 01 Day
Last follow-up date
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
2018 Year 02 Month 23 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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