| CTRI Number |
CTRI/2024/03/063614 [Registered on: 05/03/2024] Trial Registered Prospectively |
| Last Modified On: |
11/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Things that affect medication taking patterns in Obsessive compulsive disorder patients in a tertiary care hospital |
|
Scientific Title of Study
|
Assessment of medication adherence and quality of life in patients with obsessive compulsive disorder in a tertiary care hospital:a cross-sectional observational study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suman Saha |
| Designation |
Post graduate trainee |
| Affiliation |
Institute of post Graduate Medical Education and Research |
| Address |
Department of Pharmacology, 244 AJC Bose Road,Kolkata
KOLKATA-700020
West Bengal
India
Kolkata
WEST BENGAL
700020
India |
| Phone |
7980008726 |
| Fax |
|
| Email |
sahasuman61@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gairik Sengupta |
| Designation |
Associate Professor |
| Affiliation |
Institute of Post Graduate Medical Education and Research |
| Address |
Department of Pharmacology,IPGMER
AJC Bose Road,Kolkata
KOLKATA-700020
West Bengal
India
Kolkata
WEST BENGAL
700020
India |
| Phone |
9874621539 |
| Fax |
|
| Email |
drgairiksengupta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Suman Saha |
| Designation |
Post graduate trainee |
| Affiliation |
Institute of post Graduate Medical Education and Research |
| Address |
Department of Pharmacology, 244 AJC Bose Road,Kolkata
KOLKATA-700020
West Bengal
India
Kolkata
WEST BENGAL
700020
India |
| Phone |
7980008726 |
| Fax |
|
| Email |
sahasuman61@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of postgraduate Medical Education and Research
244 AJC Bose Road KOLKATA-700020 |
|
|
Primary Sponsor
|
| Name |
Institute of postgraduate Medical Education and Research |
| Address |
244 AJC Bose Road,Kolkata
KOLKATA-700020
West Bengal
India |
| Type of Sponsor |
Government 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 Suman Saha |
Institute of postgraduate Medical Education and Research |
Department of Pharmacology, 244 AJC Bose Road,Kolkata
KOLKATA-700020
West Bengal
India
Kolkata
WEST BENGAL |
7980008726
sahasuman61@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGME&R Research oversight committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F605||Obsessive-compulsive personality disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
OCD patients diagnosed as per ICD-10 and under stable prescribed fixed regime of medicines for 3 months and patients able to comprehend English and Bengali |
|
| ExclusionCriteria |
| Details |
Any acute illness likely to influence medication adherence, co existing psychiatric disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Possible factors behind poor adherence in 200 patients groups. |
1 year 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patients behavior regarding medication intake will be different between groups. |
18 months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
16/03/2024 |
| 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)
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
|
Primary objective : 1. To assess the proportion of obsessive compulsive disorder patients adherent to their prescribed medications 2. To assess the factors influencing adherence to medication among these patients Secondary objective: 1. To assess the quality of life among OCD patients 2. To assess the attitude of OCD patients about psychiatric medications
Background of the study: Obsessive compulsive disorder is fourth common mental disorder worldwide. Psychopharmacotherapy, psychotherapy or combination of both are the current available treatment modalities. Moderate to severe OCD treatment requires psychopharmacological treatment options in addition to CBT ( cognitive behavioral therapy). Quality of life is impaired in patients with OCD especially in presence of co morbid conditions. Psychotherapy and medications are useful to improve Quality of life in OCD patients.
Methodology: Patients of OCD from the outpatient Department of psychiatry will be recruited as per inclusion criteria. Data regarding socio-demographic details will be collected. Patients will be assessed using the following scales 1.Medication adherence rating scale (MARS) 2.Yale-Brown obsessive compulsive scale(Y-BOCS) 3.Hamilton depression rating scale (HAM-D Scale) 4.Drug attitude inventory-10(DAI-10) 5.World health organization quality of life Bref(WHOQOL-BREF)
Expected Outcome- Possible factors behind poor adherence in the study may assist in better understanding of patient behavior regarding medication intake and suggest ways to improve therapeutic Outcome in the long run. |