UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025558 |
|---|---|
| Receipt number | R000029412 |
| Scientific Title | A Cross-Sectional Survey on Problem Drinking in Depressive Patients Receiving Primary Psychiatric Care |
| Date of disclosure of the study information | 2017/01/06 |
| Last modified on | 2018/02/14 16:50:31 |
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Basic information
Public title
A Cross-Sectional Survey on Problem Drinking in Depressive Patients Receiving Primary Psychiatric Care
Acronym
A Cross-Sectional Survey on Problem Drinking in Depressive Patients
Scientific Title
A Cross-Sectional Survey on Problem Drinking in Depressive Patients Receiving Primary Psychiatric Care
Scientific Title:Acronym
A Cross-Sectional Survey on Problem Drinking in Depressive Patients
Region
| Japan |
Condition
Condition
Depression
Classification by specialty
| Psychosomatic Internal Medicine | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal the frequency of depressive patients with a drinking habit who are treated at the outpatient psychiatry clinic and a rate for concurrent alcohol dependence among patients with a drinking habit. Furthermore, to investigate a correlation between the degree of alcohol dependence and the severity of depression.
Basic objectives2
Others
Basic objectives -Others
This study will investigate the frequency of drinking habit and potential alcohol dependence in depressive patients receiving primary psychiatric care, as well as their patient information, problems arising from concurrent alcohol dependence and patients' treatment needs. Furthermore, a correlation between the degree of alcohol dependence and the severity of depression will be evaluated to exploratory examine the importance of the treatment of alcohol dependence for these patients.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The prevalence of alcoholism, alcohol abuse, and suspected alcoholism in patients with depression who engage in habitual drinking
Key secondary outcomes
Correlations between the severity of depression as well as social life and drinking parameters (amount of alcohol consumption, number of days of heavy drinking, severity of alcoholism), and the prevalence of habitual drinking in patients with depression
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
1) Patients who are diagnosed as having major depression according to the International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10)
2) Patients aged 20 years or older at the time of informed consent
Key exclusion criteria
1) Patients who are determined by researchers that the credibility of their responses cannot be expected
2) Patients who were previous participation in this study, including at another hospital
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiaki Kanzaki |
Organization
Otsuka Pharmaceutical Co.,Ltd.
Division name
Department of Medical Affairs
Zip code
Address
Shinagawa Grand Central Tower 2-16-4 Konan, Minato-ku, Tokyo 108-8242, Japan
TEL
03-6361-7337
hayashit@otsuka.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takako Hayashi |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Department of Medical Affairs
Zip code
Address
Shinagawa Grand Central Tower 2-16-4 Konan, Minato-ku, Tokyo 108-8242, Japan
TEL
03-6361-7337
Homepage URL
hayashit@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
| 2017 | Year | 01 | Month | 06 | 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
Completed
Date of protocol fixation
| 2016 | Year | 10 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 06 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Concurrent alcohol dependence in depressive patients is found to be an important issue, but there are few survey reports on the rate of concurrent alcohol dependence and its previous stage, drinking habit, in Japan. Also, a correlation between depression and alcohol dependence has been reported, but there is no survey report on correlation with each severity.
Management information
Registered date
| 2017 | Year | 01 | Month | 06 | Day |
Last modified on
| 2018 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029412
| 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 |
