| CTRI Number |
CTRI/2021/09/036862 [Registered on: 27/09/2021] Trial Registered Prospectively |
| Last Modified On: |
23/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
Study on assessment of psychotropic drug prescribing pattern in schizophrenic patients |
|
Scientific Title of Study
|
Assessment of psychotropic drug prescribing pattern in patients with schizophrenia: A Prospective observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Suyimpokla |
| Designation |
M Pharm Student |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, NGSMIPS, Paneer, Derelakatte, Mangaluru
Paneer, Derelakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7478820157 |
| Fax |
|
| Email |
suyimpoklaimsong3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Juno J Joel |
| Designation |
Assistant Professor and HOD |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, NGSMIPS, Paneer, Derelakatte, Mangaluru
Paneer, Derelakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9480470727 |
| Fax |
|
| Email |
Junojoel@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Satheesh Rao |
| Designation |
Professor |
| Affiliation |
Justice K.S Hegde charitable Hospital |
| Address |
Department of Psychiatry, Justice K.S Hegde charitable Hospital
Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9845085561 |
| Fax |
|
| Email |
dr_satheeshrao@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Self, Department of Psychiatry, Justice KS Hegde charitable hospital, Derelakatte, Mangaluru, Karnataka- 575018 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| suyimpokla |
Justice K.S Hegde charitable Hospital |
Department of Psychiatry, Derelakatte, Mangaluru
Dakshina Kannada
KARNATAKA |
7478820157
suyimpoklaimsong3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NGSM Institute of pharmaceutical sciences Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F209||Schizophrenia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with schizophrenia according to the diagnostic and statistical Manual of Mental Disorders, fourth edition or the International Classification of Disease, 10th Revision (ICD-10).
Patients aged 18 years and above
Patients treated with psychotics drugs on inpatient at the hospital.
|
|
| ExclusionCriteria |
| Details |
Patients with major medical illness.
Patients not willing to participate
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Analysis of prescribing pattern of psychotropic drugs will serve as a baseline data to help clinicians to implement safe and cost effective treatment to the patients. |
8 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This study will provide a framework for reasonable prescribing and also reduce polypharmacy by following the guidelines |
8 months |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
27/09/2021 |
| 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="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A prospective obsrvational study will be carry out to study the prescription pattern of psychotropic drug in patients with schizophrenic disorder. The objective of this study is to assess the prescribing pattern and to compare it with the recommended guidelines. A total of 75 patients will be included. All the necessary and relevant data will be obtained from patients demographic details, patient case files and treatment charts, and informed consent form. Analysis of psychotropic drugs will serve as a baseline data to help clinicians to implement safe and cost effective treatment to the patients. Thereby, this study will give the detailed information regarding prescribing pattern of psychotropic drugs in patients with schizophrenia. |