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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||||
Condition | Patients diagnosed as having ICD-10 (International Classification of Disease, 10th revision) F2 or F3 with psychotic symptoms | ||||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 150 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |