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Name
UMIN ID

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000046501
Receipt No. R000053058
Scientific Title Patterns and impact of sociodemographic factors in anxious and depressed alcohol dependent patients
Date of disclosure of the study information 2022/09/07
Last modified on 2021/12/28

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Basic information
Public title Sociodemographic factors in anxious and depressed alcoholics
Acronym SADA
Scientific Title Patterns and impact of sociodemographic factors in anxious and depressed alcohol dependent patients
Scientific Title:Acronym SDADA
Region
Asia(except Japan)

Condition
Condition Psychiatry
Classification by specialty
Medicine in general Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the patterns and impact of sociodemographic factors (age, gender, background, education level, employment status, occupation, marital status, and family type) in anxious and depressed alcohol dependent patients.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes Influence of sociodemographic factors on anxiety and depression in alcoholics
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking
Concealment Numbered container method

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Behavioural Therapy
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
18 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria Patients above 18years of age, of either sex, fulfilling the diagnostic criteria of alcohol dependence according to severity of alcohol dependence questionnaire (SADQ) participated in the study
Key exclusion criteria Patients with known history of psychiatric illness other than depressive disorders or any concomitant substance dependence, gross brain damage as reflected by gross cognitive impairment, severe medical complication, or evidence of drinking during the hospital stay were excluded.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Puneet
Middle name
Last name Mathur
Organization Rama Medical College and Research center
Division name Hapur
Zip code 245305
Address National highway Pilkhuwa
TEL 0122-2327319
Email principal@ramamedicalcolleges.com

Public contact
Name of contact person
1st name Anuj
Middle name
Last name Mehra
Organization Anuj Enterprises
Division name Delhi
Zip code 110001
Address Preet Vihar delhi
TEL 01143543206
Homepage URL
Email anujsafety@gmail.com

Sponsor
Institute Rama Medical College and Research Center
Institute
Department

Funding Source
Organization Self-funded
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 GS Medical College
Address NH Pilkhuwa
Tel 919999055223
Email brahul2371@gmail.com

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
2022 Year 09 Month 07 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
2021 Year 01 Month 08 Day
Date of IRB
2021 Year 03 Month 07 Day
Anticipated trial start date
2021 Year 05 Month 01 Day
Last follow-up date
2022 Year 05 Month 01 Day
Date of closure to data entry
2022 Year 08 Month 01 Day
Date trial data considered complete
2022 Year 09 Month 28 Day
Date analysis concluded
2022 Year 10 Month 08 Day

Other
Other related information

Management information
Registered date
2021 Year 12 Month 28 Day
Last modified on
2021 Year 12 Month 28 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053058

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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