UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000034878 |
|---|---|
| Receipt number | R000039695 |
| Scientific Title | Intervention using the open dialogue for hearing voices and suspicions |
| Date of disclosure of the study information | 2018/11/13 |
| Last modified on | 2022/05/22 17:27:08 |
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Basic information
Public title
Intervention using the open dialogue for hearing voices and suspicions
Acronym
The open dialogue for hearing voices and suspicions
Scientific Title
Intervention using the open dialogue for hearing voices and suspicions
Scientific Title:Acronym
The open dialogue for hearing voices and suspicions
Region
| Japan |
Condition
Condition
Schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the safety of intervention using the open dialogue in the acute phase of initial onset schizophrenia in a prospective study.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Whether CGI-SS Part 1 is 4 (Severly suicidal) or 5 (Attempted suicide) or Part 2 is 6 (Much worse) or 7 (Very much worse). Presence or absence of clinically significant self-injury, other harm, or violent behavior causing damage to the object
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
| Other |
Interventions/Control_1
the open daialogue
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Schizophrenia, Mood disorder, Pervasive developmental disorder(ICD-10 F2, F3, F84)
2)No treatment from the first episode
3) without restriction of the age and the gender
4) documentary consent by free will of the patient person himself (the agreement which chooses one in case of less than 16 years old as an ascent document) and the family is got after enough informed consent in case of participation in this research.
Key exclusion criteria
1) Patients who only want drug therapy
2) Patients who do not wish the open dialogue
3) Patients other than schizophrenia or mood disorder or Pervasive developmental disorder(F 2 in ICD - 10)
4) Patients are judged inappropriate as a research subject by research director or research worker
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Reizo |
| Middle name | |
| Last name | Kaneda |
Organization
Kanazawa University Hospital
Division name
Department of Psychiatry
Zip code
920-8641
Address
13-1Takaramachi,Kanazawa,Ishikawa,920-8641
TEL
0762652307
reizo@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Rie |
| Middle name | |
| Last name | Nishioka |
Organization
Kanazawa University Graduate School of Medical Science
Division name
Department of Psychiatry and Behavioral Science
Zip code
920-8641
Address
13-1Takaramachi,Kanazawa,Ishikawa,920-8641
TEL
0762652307
Homepage URL
re-neuro@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
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
Institutional Review Board of Kanazawa University Hospital
Address
13-1Takaramachi,Kanazawa,Ishikawa,920-8641
Tel
0762652048
hpsangak@adm.kanazawa-u.ac.jp
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 | 11 | Month | 13 | 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
0
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
Terminated
Date of protocol fixation
| 2018 | Year | 11 | Month | 06 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 13 | Day |
Last modified on
| 2022 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039695
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
