UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007800 |
|---|---|
| Receipt number | R000009189 |
| Scientific Title | Pharmacogenetic study of autonomic nervous function in psychiatric patients |
| Date of disclosure of the study information | 2012/04/20 |
| Last modified on | 2015/11/25 15:13:32 |
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Basic information
Public title
Pharmacogenetic study of autonomic nervous function in psychiatric patients
Acronym
Pharmacogenetic study of autonomic nervous function in psychiatric patients
Scientific Title
Pharmacogenetic study of autonomic nervous function in psychiatric patients
Scientific Title:Acronym
Pharmacogenetic study of autonomic nervous function in psychiatric patients
Region
| Japan |
Condition
Condition
psychiatric disease
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
We investigated the autonomic nervous function in psychiatric patients and examined the influence of pharmacogenetic influence of psychotropic drugs.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Level of psychiatric disease, body height/weight, autonomic nervous activity(ECG), genetic polymorphism
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Genomic DNA was extracted from peripheral white blood cells from all patients using standard techniques.
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
Subjects are psychiatric disease patients including schizophrenia and mood disorders.
Control subjects are healthy subjects.
Key exclusion criteria
Patients with preexisting disease known to affect autonomic nervous system activity are excluded.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ikuko Kishida |
Organization
Yokohama City University School of medicine
Division name
Department of Psychiatry
Zip code
Address
3-9, Fukuura, Kanazawa-Ku, Yokohama
TEL
045-787-2800
kasuga@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ikuko Kishida |
Organization
Yokohama City University School of medicine
Division name
Department of Psychiatry
Zip code
Address
3-9, Fukuura, Kanazawa-Ku, Yokohama
TEL
045-787-2800
Homepage URL
kasuga@yokohama-cu.ac.jp
Sponsor or person
Institute
Ikuko Kishida
Institute
Department
Personal name
Funding Source
Organization
None
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 20 | 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
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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | 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
Management information
Registered date
| 2012 | Year | 04 | Month | 20 | Day |
Last modified on
| 2015 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009189
| 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 |
