UMIN-CTR Clinical Trial

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
Email	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
Email	re-neuro@med.kanazawa-u.ac.jp

Sponsor
Institute	Kanazawa University Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039695