UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022676 |
|---|---|
| Receipt number | R000026134 |
| Scientific Title | Study of searching on effect on patients with schizophrenia or mood disorders of the recovery support program using IMR (:Illness Management and Recovery) |
| Date of disclosure of the study information | 2018/03/31 |
| Last modified on | 2016/06/09 10:09:10 |
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Basic information
Public title
Study of searching on effect on patients with schizophrenia or mood disorders of the recovery support program using IMR (:Illness Management and Recovery)
Acronym
Study of searching on effect of the recovery support program using IMR
Scientific Title
Study of searching on effect on patients with schizophrenia or mood disorders of the recovery support program using IMR (:Illness Management and Recovery)
Scientific Title:Acronym
Study of searching on effect of the recovery support program using IMR
Region
| Japan |
Condition
Condition
Schizophrenia
Mood disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For the recovery support of the mental disease patient, I inspect the effectiveness of a new psychoeducational program based on IMR.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
･data of interview
･Global Assessment of Functioning Scale:GAF
･BPRS
HAM-D
YMRS
･RAS
･SISR-A/SISR-B
･IMR Scale
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Individuals with Schizophrenia
Individuals with Depression
Individuals with Bipolar disorder
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)The person who uses Kyoto University Hospital daycare more than a half year
2)Individuals with Schizophrenia or Mood disorder
Key exclusion criteria
1)minor
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuri Sasaki |
Organization
Kyoto University Hospital
Division name
Department of daycare
Zip code
Address
Shougoin Kawaramachi54. Sakyou-ku,Kyoto
TEL
075-751-3393
sy328@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuri Sasaki |
Organization
Kyoto University Hospital
Division name
Department of daycare
Zip code
Address
Shougoin Kawaramachi54. Sakyou-ku,Kyoto
TEL
075-751-3393
Homepage URL
sy328@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of daycare, Kyoto University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Preinitiation
Date of protocol fixation
| 2016 | Year | 05 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 09 | Day |
Last modified on
| 2016 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026134
