UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Cross-Sectional Survey on Problem Drinking in Depressive Patients Receiving Primary Psychiatric Care
Title of the study (Brief title)	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	Yoshiaki Kanzaki
Organization	Otsuka Pharmaceutical Co.,Ltd.
Division name	Department of Medical Affairs
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	Takako Hayashi
Organization	Otsuka Pharmaceutical Co., Ltd.
Division name	Department of Medical Affairs
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

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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