| CTRI Number |
CTRI/2025/10/096429 [Registered on: 23/10/2025] Trial Registered Prospectively |
| Last Modified On: |
18/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Medication Use and Safety in Older Adults with Mental Health Conditions |
|
Scientific Title of Study
|
Assessment of Polypharmacy, Anticholinergic Burden, and Drug-Drug Interactions in
Geriatric Psychiatry: A Cross-Sectional Study at a Tertiary Care Hospital |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suraj B |
| Designation |
Professor |
| Affiliation |
SNMC and HSK Hospital and Research Center |
| Address |
Department of Pharmacology First Floor SNMC and HSK Hospital and Research Center
Bagalkot
KARNATAKA
587103
India
Bagalkot
KARNATAKA
587103
India |
| Phone |
8861083454 |
| Fax |
|
| Email |
drsurajpanchal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Suraj B |
| Designation |
Professor |
| Affiliation |
SNMC and HSK Hospital and Research Center |
| Address |
Department of Pharmacology First Floor SNMC and HSK Hospital and Research Center
Bagalkot
KARNATAKA
587103
India
KARNATAKA
587103
India |
| Phone |
8861083454 |
| Fax |
|
| Email |
drsurajpanchal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Suraj B |
| Designation |
Professor |
| Affiliation |
SNMC and HSK Hospital and Research Center |
| Address |
Department of Pharmacology First Floor SNMC and HSK Hospital and Research Center
Bagalkot
KARNATAKA
587103
India
KARNATAKA
587103
India |
| Phone |
8861083454 |
| Fax |
|
| Email |
drsurajpanchal@gmail.com |
|
|
Source of Monetary or Material Support
|
| SNMC and HSK Hospital and Research Center Bagalkot |
|
|
Primary Sponsor
|
| Name |
Suraj B |
| Address |
Department of Pharmacology First Floor SNMC and HSK Hospital and Research Center Bagalkot |
| Type of Sponsor |
Other [Self] |
|
|
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 Suraj B |
SNMC anddHSK Hospital and Research Center |
Room no 101 First Floor OPD Block
Department of Psychiatry
SNMC and HSK Hospital Bagalkot
Karnataka
Bagalkot
KARNATAKA |
8861083454
drsurajpanchal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SNMC INSTITUITIONAL ETHICS COMMITTEE ON HUMAN SUBJECTS RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F258||Other schizoaffective disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients aged more than or equal to 60 years, diagnosed with a Psychiatric disorder (ICD 10 Classification)
2) On at least one psychotropic medication
3) Receiving outpatient psychiatric care
4) Willing to provide informed consent |
|
| ExclusionCriteria |
| Details |
1) Patients with incomplete medication records.
2) Terminally ill patients or those on palliative care and or refusal to participate. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of Polypharmacy, anticholinergic burden and Drug Drug Interactions in patients attending Tertiary Care Center |
At the end of data collection, which is at 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify the most common medications contributing to anticholinergic burden & drug interactions. |
At the end of data collection which is at 6 months. |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
11/11/2025 |
| 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="0"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - By personal email of PI Dr Suraj B (drsurajpanchal@gmail.com) to the study investigator
- For how long will this data be available start date provided 20-10-2026 and end date provided 19-10-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Polypharmacy is common in geriatric psychiatry due to comorbid conditions, increasing the likelihood
of adverse drug reactions, anticholinergic burden (ACB), and drug drug interactions (DDIs). These
factors contribute to cognitive decline, falls, and hospitalization. This cross-sectional study analyzes
prescriptions of geriatric patients in a tertiary care psychiatric hospital. Data on prescribed
medications will be collected, and tools such as the Anticholinergic Cognitive Burden Scale and the Medscape Interaction Checker will assess ACB and DDIs, respectively. The study identifies high risk medications and
explores correlations between polypharmacy, ACB, and DDIs. Findings from this study will also highlights prescribing patterns, potential risks, and the
need for deprescribing strategies to optimize geriatric mental health care. Expected outcomes include
insights into medication safety, recommendations for minimizing ACB and DDIs, and improved clinical
guidelines for geriatric psychiatric patients. |