A multicenter randomized control trial in Japan of comprehensive early intervention in first-episode psychosis.
Not Applicable
- Conditions
- Patients diagnosed as having ICD-10 (International Classification of Disease, 10th revision) F2 or F3 with psychotic symptoms
- Registration Number
- JPRN-UMIN000005092
- Lead Sponsor
- Department of Neuropsychiatry, Graduate School of Medicine, the University of Tokyo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Global Assessment of Functioning, Function domain (GAF-F) scores in the first endpoint (18 months after registration)
- Secondary Outcome Measures
Name Time Method 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).