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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025558
Receipt No. 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

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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
Email 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
Email hayashit@otsuka.jp

Sponsor
Institute Otsuka Pharmaceutical Co., Ltd.
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029412

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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