UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020059 |
|---|---|
| Receipt number | R000023171 |
| Scientific Title | Bio-psycho-social factors which affect onset and course of mental diseases |
| Date of disclosure of the study information | 2016/01/04 |
| Last modified on | 2023/01/04 20:38:34 |
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Basic information
Public title
Bio-psycho-social factors which affect onset and course of mental diseases
Acronym
Bio-psycho-social factors which affect mental diseases
Scientific Title
Bio-psycho-social factors which affect onset and course of mental diseases
Scientific Title:Acronym
Bio-psycho-social factors which affect mental diseases
Region
| Japan |
Condition
Condition
1 Organic, including symptomatic, mental disorders
2 Schizophrenia, schizoaffective and delusional disorders
3 Mood disorders
4 Neurotic, stress-related and somatoform disorders
5 Behavioural syndromes associated with physiological disturbances and physical factors
6 Disorders of psychological development
7 Epilipsy
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the impact of various bio-psycho-social factors on psychiatric diseases
Basic objectives2
Others
Basic objectives -Others
study about pathological state
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
clinical symptoms
Key secondary outcomes
eye-movement test, event-related potential (ERP), neuro-cognitivee-battery, social-cognitive-battery, MRI, PET, SPECT, social background
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
person who have the targeted psychiatric disease(s)
Key exclusion criteria
person who cannot educe the tests
Target sample size
1400
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Kusumi |
Organization
Hokkaido University, Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
060-8638
Address
Kita 15 Nishi 7, Kita-ku, Sapporo, Hokkaido
TEL
0117065160
hashinao@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Hashimoto |
Organization
Hokkaido University, Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
060-8638
Address
Kita 15 Nishi 7, Kita-ku, Sapporo, Hokkaido
TEL
0117065160
Homepage URL
hashimona@gmail.com
Sponsor or person
Institute
Department of Psychiatry, Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
No
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Hokkaido University Hospital Ethics Committee
Address
Kita14 Nishi5, Kita-ku, Sapporo, Hokkaido
Tel
011-706-7934
recjimu@huhp.hokudai.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
北海道大学病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 04 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/29201642/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/29201642/
Number of participants that the trial has enrolled
387
Results
A total of 387 patients were included for major psychiatric disorders, including schizophrenia, bipolar disorder, and major depressive disorder.
The main results of the analysis revealed that the volume of the hippocampus was smaller and that of the globus pallidus was larger in patients with schizophrenia than in normal subjects, and that this was influenced by antipsychotic drugs.
Results date posted
| 2023 | Year | 01 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 387 patients were included for major psychiatric disorders, including schizophrenia, bipolar disorder, and major depressive disorder.
Participant flow
Psychosocial evaluation, psychiatric symptom evaluation, brain imaging, and neurophysiological testing were performed on patients who gave consent.
Adverse events
No serious adverse events observed.
Outcome measures
Psychosocial evaluation, psychiatric symptom evaluation, brain imaging, and neurophysiological testing
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 04 | Month | 28 | Day |
Date of IRB
| 2010 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2010 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Design:Prospective observational study
Eligibility: All the subjects who visits Department of Psychiatry, Hokkaido University Hospital from August 2010 to March 2018
Items: demographic background, clinical measurement, event related potential, structural MRI, functional MRI, social cognition, neurocognition, eye movement
Management information
Registered date
| 2015 | Year | 12 | Month | 03 | Day |
Last modified on
| 2023 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023171
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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