UMIN-CTR Clinical Trial

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
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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
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IRB Contact (For public release)
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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
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Baseline Characteristics
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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
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