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

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 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


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

Value
https://center6.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