UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026241 |
|---|---|
| Receipt number | 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 | 2019/08/26 19:31:54 |
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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
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
kanahara@faculty.chiba-u.jp
Sponsor or person
Institute
Department of Psychiatry, Chiba University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029969
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