UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005092 |
|---|---|
| Receipt number | R000005788 |
| Scientific Title | A multicenter randomized control trial in Japan of comprehensive early intervention in first-episode psychosis. |
| Date of disclosure of the study information | 2011/02/15 |
| Last modified on | 2017/02/20 09:48:47 |
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Basic information
Public title
A multicenter randomized control trial in Japan of comprehensive early intervention in first-episode psychosis.
Acronym
Japanese Comprehensive Approach to Psychosis (J-CAP) study.
Scientific Title
A multicenter randomized control trial in Japan of comprehensive early intervention in first-episode psychosis.
Scientific Title:Acronym
Japanese Comprehensive Approach to Psychosis (J-CAP) study.
Region
| Japan |
Condition
Condition
Patients diagnosed as having ICD-10 (International Classification of Disease, 10th revision) F2 or F3 with psychotic symptoms
Classification by specialty
| Psychiatry | Rehabilitation medicine | Adult |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether comprehensive early intervention services will be effective for patients with first-episode psychosis in Japan.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Global Assessment of Functioning, Function domain (GAF-F) scores in the first endpoint (18 months after registration)
Key secondary outcomes
GAF-F, Global Assessment of Functioning, Symptom domain (GAF-S), Positive And Negative Symptom Scales (PANSS), the World Health Organization Quality Of Life 26-item version (WHO-QOL26), care satisfaction, educational and vocational recovery rate, relapse rate, lost to follow-up rate, self-harm and suicidal attempt rate, suicide rate, number of visit to out-patient units, days of stay in hospital, Brief Evaluation of Medication Influences and Beliefs (BEMIB), and direct and indirect costs at each endpoint (18 months, 36 months, and 60 months).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Casemanagement (CM) group: Participants will receive standard medical care and additional case management from well-trained case managers about their symptoms and daily activities for 18 months after registration. Case managers will promote participants' recovery and social participation in cooperation with the early intervention team, using combination of cognitive behavioral therapeutic approach, psychoeducational approach, family intervention, discharge support, and pharmacological therapy in accordance with the guideline for first-episode psychosis. After 18-month follow-up, the participants will receive only standard medical care at each site.
Interventions/Control_2
Standard care (SC) group: Participants receive only standard medical care at each site.
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
| 15 | years-old | <= |
Age-upper limit
| 35 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. within 5 years from onset of psychotic symptoms.
2. first-episode psychosis.
3. live in the catchment area of each site.
4. have presented written informed consent to the ethical committee of each site, according to the Declaration of Helsinki after having been given a complete explanation of this study.
Key exclusion criteria
1. premorbid IQ under 80.
2. unable to have sufficient communication in Japanese.
3. need care for any organic mental disorder.
4. need inpatient care for any physical condition.
5. have a history of dependency on alcohol and/or any other substance of abuse.
6. under physical restraint and/or seclusion.
7. have received electro convulsive therapy and/or transcranial magnetic stimulation therapy within the past month.
8. presently in involuntary hospitalization.
9. have not received the explanation of one's condition or diagnosis from psychiatrists.
10. regarded as inappropriate by the physician in charge for any other reason.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyoto Kasai |
Organization
the University of Tokyo
Division name
Department of Neuropsychiatry, Graduate School of Medicine
Zip code
Address
CRC-A, University Hospital, 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan
TEL
+81-3-3815-5411
kasaik-tky@umin.net
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinsuke Koike |
Organization
the University of Tokyo
Division name
Faculty of Arts and Sciences
Zip code
Address
3-8-1 Komaba, Meguro-ku, Tokyo 153-8902, Japan
TEL
+81-3-5454-4327
Homepage URL
skoike-tky@umin.ac.jp
Sponsor or person
Institute
Department of Neuropsychiatry, Graduate School of Medicine, the University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Grants from the Ministry of Health, Labour, and Welfare (Health and Labour Sciences Research Grants, Research on Psychiatric and Neurological Diseases and Mental Health, H22-seishin-ippan-015).
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
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
東京大学医学部付属病院（東京都）、東京都立松沢病院（東京都）、三重県立こころの医療センター（三重県）、社会医療法人居仁会（三重県）、岡山県精神科医療センター（岡山県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 15 | Day |
Related information
URL releasing protocol
http://plaza.umin.ac.jp/arms-ut/feprct.html
Publication of results
Partially published
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
Main results already published
Date of protocol fixation
| 2011 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2017 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2017 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 15 | Day |
Last modified on
| 2017 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005788
