UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019297 |
|---|---|
| Receipt number | R000022284 |
| Scientific Title | The effect of pharmacotherapy and psychosocial therapy on cognitive function and life style |
| Date of disclosure of the study information | 2015/10/09 |
| Last modified on | 2022/10/14 09:31:49 |
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Basic information
Public title
The effect of pharmacotherapy and psychosocial therapy on cognitive function and life style
Acronym
The effect of pharmacotherapy and psychosocial therapy on cognitive function and life style
Scientific Title
The effect of pharmacotherapy and psychosocial therapy on cognitive function and life style
Scientific Title:Acronym
The effect of pharmacotherapy and psychosocial therapy on cognitive function and life style
Region
| Japan |
Condition
Condition
Schizophrenia, mood disorder, dementia (mild), eating disorder, sleep disorder, autism spectrum disorder, breathing-related sleep disorder and epilepsy
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of pharmacotherapy and psychosocial therapy on cognitive function, quality of life, and daily life
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Driving performance by driving simulator
Key secondary outcomes
Sexual function screening, cognitive function (attention, memory, executive function), ocular motion, sleep sheet, compact electroencephalograph, assessment of psychiatric symptoms, assessment of driving behavior
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with schizophrenia, mood disorder, sleep disorder, neurodevelopmental disorder, breathing related sleep disorder or epilepsy who give consent to to study participation
Key exclusion criteria
under 20 years old
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Norio |
| Middle name | |
| Last name | Ozaki |
Organization
Nagoya University Graduate School of Medicine
Division name
Pathophysiology of Mental Disorders
Zip code
466-8550
Address
Tsurumaicho 65, showa-ku, Nagoya City, Aichi, Japan
TEL
+81527442282
ozaki-n@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Kunihiro |
| Middle name | |
| Last name | Iwamoto |
Organization
Nagoya University Graduate School of Medicine
Division name
Psychiatry
Zip code
466-8550
Address
Tsurumaicho 65, showa-ku, Nagoya City, Aichi, Japan
TEL
+81527442282
Homepage URL
iwamoto@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Graduate School of Medicine and Nagoya University Hospital ethics review committee
Address
Tsurumaicho 65, showa-ku, Nagoya City, Aichi, Japan
Tel
052-744-2479
ethics@med.nagoya-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
| 2015 | Year | 10 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 04 | Month | 12 | Day |
Date of IRB
| 2010 | Year | 04 | Month | 12 | Day |
Anticipated trial start date
| 2010 | Year | 04 | Month | 12 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Based on case-control and longitudinal model. We recruit a healthy adult without history of psychiatric disorders
Management information
Registered date
| 2015 | Year | 10 | Month | 09 | Day |
Last modified on
| 2022 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022284
| 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 |
