UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008644 |
|---|---|
| Receipt number | R000010104 |
| Scientific Title | Analysis of sociodemographic,pharmacotthreapy-relatedand illness-related factors affecting neurocognitive disturbance in patients with schizophrenia |
| Date of disclosure of the study information | 2012/08/08 |
| Last modified on | 2012/08/08 09:52:53 |
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Basic information
Public title
Analysis of sociodemographic,pharmacotthreapy-relatedand illness-related factors affecting neurocognitive disturbance in patients with schizophrenia
Acronym
Analysis of factors affecting cognitive disturbance in patients with schizophrenia
Scientific Title
Analysis of sociodemographic,pharmacotthreapy-relatedand illness-related factors affecting neurocognitive disturbance in patients with schizophrenia
Scientific Title:Acronym
Analysis of factors affecting cognitive disturbance in patients with schizophrenia
Region
| Japan |
Condition
Condition
Schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine how sociodemographical, illness-related and pharmacotherapy-related factors influence cognitive disturbance.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The degree of contributions of sociodemographic, illness-related, and pharmacotherapy-related factors to the scores of neurocognitive tests
Key secondary outcomes
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
| 15 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All the patients had been diagnosed as schizophrenia, had been taking a stable dose of antipsychotics for at least 4 weeks.
Key exclusion criteria
None of the patients had a history of seizure disorder, renal insuffficiency, dementia, substance misuse, including alcohol problems.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | N |
Organization
Graduate School of Medicine, Hokkaido University
Division name
Department of Psychiatry
Zip code
Address
North15, West7, Sapporo, Japan
TEL
011-706-5160
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Hashimoto |
Organization
Graduate School of Medicine, Hokkaido University
Division name
Department of Psychiatry
Zip code
Address
North15, West7, Sapporo, Japan
TEL
011-706-5160
Homepage URL
Sponsor or person
Institute
Graduate School of Medicine, Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Department of Psychiatry, Graduate School of Medicine, Hokkaido University
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
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
北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 08 | 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
Completed
Date of protocol fixation
| 2005 | Year | 01 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A multiple linear regression model suggested that the contributions of sociodemographic, illness-related, and pharmacotherapy-related factors to neurocognitive impairment were limited. The disorganized component of the PANSS was related to neurocognitive impairment A negative effect of first-generation antipsychotics, compared with second-generation antipsychotics, was only seen on the Trail Making Test (TMT), but this effect was stronger than the effect of the extra pyramidal side effects or that of the anticholinergics.
Management information
Registered date
| 2012 | Year | 08 | Month | 08 | Day |
Last modified on
| 2012 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010104
