| 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
|
|
|
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
|
|
|
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. |