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CTRI Number  CTRI/2024/07/070603 [Registered on: 15/07/2024] Trial Registered Prospectively
Last Modified On: 14/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Comparing determinants of Intimate Partner Violence between bipolar disorder and substance abuse  
Scientific Title of Study   To study the determinants of Intimate Partner Violence in Bipolar and related disorders compared to the substance use disorders. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vinay Kumar 
Designation  Junior Resident 
Affiliation  Government medical college Patiala 
Address  Room no 2 department of psychiatry government medical college and Rajindra hospital Patiala Sangrur Road 147002 Punjab India
Model De-addiction center near State Bank of India Room no 3 Patiala 147001 Punjab India
Patiala
PUNJAB
147001
India 
Phone  07895423003  
Fax    
Email  kumarvinay3241@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajnish Raj 
Designation  Professsor and Head of Department 
Affiliation  Government medical college Patiala 
Address  Room no 1 Department of psychiatry Government Medical College and Rajindra hospital Patiala Sangrur Road Punjab 147001 India
Model De-addiction center room number 2 near psychiatry department Patiala 147001 Punjab India
Patiala
PUNJAB
147001
India 
Phone  9814913599  
Fax    
Email  Profheadpsy@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Rohit Garg 
Designation  Professsor 
Affiliation  Government medical college Patiala 
Address  Room no 10 department of psychiatry government medical college and Rajindra hospital Patiala Sangrur Road Punjab 147001 India
Model De-addiction center Room no 11 near State Bank of India Patiala 147001 Punjab India
Patiala
PUNJAB
147001
India 
Phone  9888145477  
Fax    
Email  jrpsychiatry@gmail.com  
 
Source of Monetary or Material Support  
Department of psychiatry government medical college Patiala Sangrur road 147001 Punjab India 
 
Primary Sponsor  
Name  Government Medical College Patiala Punjab 
Address  Government Medical College Patiala Sangrur road 147001 PUNJAB India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vinay Kumar  Government Medical College Patiala  Room no 2 department of psychiatry government medical college and Rajindra hospital Patiala Sangrur Road Punjab 147001 India
Patiala
PUNJAB 		 07895423003

kumarvinay3241@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE Govt. Medical College, Patiala  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F317||Bipolar disorder, currently in remission,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients in group 1 should fulfill the criteria of bipolar and related disorders (BP-I and BP-II) as DSM-5 criteria.
Patients in group 2 should fulfill the criteria of substance use disorders as DSM-5 criteria.
Patient should be in maintenance phase after initial treatment.
Should be in the age group of 18 to 60 years.
Patients who will give voluntary written informed consent for the study.
 
 
ExclusionCriteria 
Details  Patients refusing informed consent.
Other type of bipolar disorders.
Any other comorbidity.
Any other substance substance abuse like cannabis etc.
Age more than 60 years. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the determinants of intimate partner violence in bipolar and related disorders compared to the substance use disorders.  Outcome will be measured from the past one to two years experience using different questionnaire and scales. duation 18 months 
 
Secondary Outcome  
Outcome  TimePoints 
To identify the determinants of intimate partner violence in bipolar & related disorder compared to substance use disorders
To find various pattern of intimate partner violence between the two groups
To find impact on quality of life of intimate partner violence among the two group.
To determine correlation & association of at risk factors amongst them. 		 Outcome will be measured from the past one to two years experience by applying various scales & statistical test. duration 18 months 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

A total of N=400 subjects will be included in this study. Consecutive purposeful sampling will be done. Group-I (n=200) will be of bipolar and related disorders (BP-I, BP-II) diagnosed as per DSM-5 and Group-II (n=200) will be comprising of the substance use disorders (alcohol+opioid) who will be age and gender matched. Group-I (n=200) will be screened on Mood Disorder Questionnaire (MDQ) with cut-off score >7 as positive screen, clinician rated Bipolar index with a cut off >40 for identifying BP-I and BP-II from BP-NOS etc. Degree of severity on Young Mania Rating Scale (YMRS) with cut-off: =12 indicating mania, =3 indicating depression, =1 euthymia, and Hamilton Rating Scale for Depression (HDRS), 0-7 normal, 8-16 mild depression, 17-23 moderate depression, >23 severe depression. Group-II (n=200) will be diagnose as per DSM-5 criteria and severity will be assessed into mild, moderate and severe.Informed written consent will be taken from all the subjects. Patients fulfilling the inclusion criteria will be screened with HITS screen (hurt, insult, threatened and scream) and STaT screen (slapped, threatened, and throw), and for cause of conflict on Revised Conflict Tactic Scale (CTS 2) and quality of life on SF-36. Both the groups will be interviewed as per the questionnaire and relevant data collected.

 
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