UMIN-CTR Clinical Trial

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://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053058