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CTRI Number  CTRI/2024/06/069151 [Registered on: 19/06/2024] Trial Registered Prospectively
Last Modified On: 23/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Study to assess the amount and type of obsessive-compulsive symptoms in patients who have recovered from bipolar disorder. 
Scientific Title of Study   Prevalence and correlates of obsessive-compulsive symptoms in remitted bipolar disorder patients. 
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 Shaswata Das 
Designation  Junior Resident 
Affiliation  Kasturba Medical College and Hospital, Manipal 
Address  Department of Psychiatry, Kasturba Medical College and Hospital, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8017301803  
Fax    
Email  shaswata.kmcmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sonia Shenoy 
Designation  Associate Professor 
Affiliation  Kasturba Medical College and Hospital, Manipal 
Address  Department of Psychiatry, Kasturba Medical College and Hospital, Manipal

Udupi
KARNATAKA
576104
India 
Phone  08202923770  
Fax    
Email  sonia.shenoy@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Sonia Shenoy 
Designation  Associate Professor 
Affiliation  Kasturba Medical College and Hospital, Manipal 
Address  Department of Psychiatry, Kasturba Medical College and Hospital, Manipal

Udupi
KARNATAKA
576104
India 
Phone  08202923770  
Fax    
Email  sonia.shenoy@manipal.edu  
 
Source of Monetary or Material Support  
Department of Psychiatry, Kasturba Medical College and Hospital, Manipal, Karnataka - 576104, India. 
 
Primary Sponsor  
Name  Kasturba Medical College and Hospital 
Address  Madhav Nagar, Manipal, Karnataka - 576104, India. 
Type of Sponsor  Private 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 Shaswata Das  Kasturba Medical College and Hospital  Room no.: 33, Department of Psychiatry, OPD Block
Udupi
KARNATAKA 
8017301803

shaswata.kmcmpl2023@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - Student Research  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 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients diagnosed with bipolar type I disorder, currently in full remission and bipolar type II disorder, currently in full remission as per ICD 11.
YMRS score of ≤12.
HAM-D score of ≤7.
Patients who can give consent in English or Kannada.

 
 
ExclusionCriteria 
Details  Severe and/or decompensated medical diseases which may affect the central nervous system such as diabetes mellitus, hypertension and hypothyroidism.
Presence of active alcohol/drug use disorders, except nicotine, in the last 12 months.
Presence of schizophrenia or intellectual disability.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Frequency of obsessive-compulsive symptoms in remitted bipolar disorder patients.
It will be a one-time cross-sectional assessment which will be done at the time of recruitment during the study. 
Cross-sectional study. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Sociodemographic & clinical variables associated with obsessive-compulsive symptoms in remitted bipolar disorder patients.
2. Cognitive function deficits in remitted bipolar disorder patients, with & without comorbid obsessive-compulsive symptoms.
3. Correlation of cognitive function deficits & quality of life as well as functioning in remitted bipolar disorder patients, with & without comorbid obsessive-compulsive symptoms.

It will be a one-time cross-sectional assessment which will be done at the time of recruitment during the study. 
Cross-sectional study. 
 
Target Sample Size   Total Sample Size="117"
Sample Size from India="117" 
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)   01/07/2024 
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="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 cross-sectional observational study will be carried out over a period of around 20 months on 117 patients from Psychiatry OPD, Psychiatry and other wards, and community camps organized by the Department of Psychiatry, Kasturba Hospital, Manipal. Patients between 18-60 years of age, able to give consent in English or Kannada, diagnosed with the disease under study and satisfying the criteria as per ICD 11 will be considered. Patients will be screened for severe and/or decompensated medical diseases like diabetes mellitus, hypertension and hypothyroidism; active alcohol/drug use orders, except nicotine, in the last 12 months; schizophrenia and intellectual disability. Primary data will be collected by obtaining first-hand information from the respondents themselves regarding the socio-demographic and illness details based on a semi-structured proforma followed by administration of a series of rating scales and neuropsychological tests over a period of one to two hours to fulfill the aims and objectives of the study. Finally the data will be streamlined and statistical analysis will be carried out to assess, analyse and correlate the symptoms of the illness and findings of the study using scientific methods. No follow-ups are required.

 
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