UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046501 |
|---|---|
| Receipt number | 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 13:32:28 |
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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
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
anujsafety@gmail.com
Sponsor or person
Institute
Rama Medical College and Research Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053058
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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