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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000005092
Receipt No. 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

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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
Email 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
Email skoike-tky@umin.ac.jp

Sponsor
Institute Department of Neuropsychiatry, Graduate School of Medicine, the University of Tokyo
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005788

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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