| CTRI Number |
CTRI/2024/07/071455 [Registered on: 29/07/2024] Trial Registered Prospectively |
| Last Modified On: |
26/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study of various medications used in patients with bipolar depression like mood stabilizers, antipsychotics and antidepressants
|
|
Scientific Title of Study
|
A prescription audit of mood stabilizers, antipsychotics and antidepressants in clinically stable patients with bipolar depression: a cross sectional 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 |
Dr Nithin Rajendran |
| Designation |
Post graduate student |
| Affiliation |
Government Medical College |
| Address |
Department of Pharmacology
Government Medical College
Patiala
Patiala
PUNJAB
147001
India |
| Phone |
9544441228 |
| Fax |
|
| Email |
dr.nithinr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neetu Sharma |
| Designation |
Assistant professor |
| Affiliation |
Government Medical College |
| Address |
Department of Pharmacology
Government Medical College
Patiala
Patiala
PUNJAB
147001
India |
| Phone |
9417075783 |
| Fax |
|
| Email |
drneetusharma1975@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nithin Rajendran |
| Designation |
Post graduate student |
| Affiliation |
Government Medical College |
| Address |
Department of Pharmacology
Government Medical College
Patiala
Patiala
PUNJAB
147001
India |
| Phone |
9544441228 |
| Fax |
|
| Email |
dr.nithinr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College
Patiala
147001 |
|
|
Primary Sponsor
|
| Name |
Dr Nithin Rajendran |
| Address |
Department of Pharmacology
Government Medical College
Patiala Punjab-147001
|
| 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 Nithin Rajendran |
Government Medical College |
Department of Psychiatry
Government Medical College
Patiala 147001
Patiala
PUNJAB |
9544441228
dr.nithinr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Medical College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F313||Bipolar disorder, current episodedepressed, mild or moderate severity, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients will be adults (aged 18 years and above) diagnosed with bipolar depression as per standardized diagnostic criteria (e.g., DSM-5).
2)Patients who will be medically stable.
3)Patients of either sex
4)Participants actively receiving treatment for bipolar depression during the study period.
5)Patients who will be accompanied by reliable informants.
6)Patients and informants who give written informed consent and are willing participate in the study. |
|
| ExclusionCriteria |
| Details |
1)Individuals with acute manic or depressive episodes, as the focus is on clinically stable patients.
2)Those with a history of recent hospitalizations or significant disruptions in treatment adherence, as these factors may act as confounders.
3)Patients with comorbid psychiatric conditions that significantly impact the assessment of bipolar depression prescription audit.
4)Participants unable or unwilling to provide informed consent.
5)Patients having insufficient data or records.
6)Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Prescription audit with respect to WHO core drug use indicators-
1.Prescribing indicators
2.Patient-care indicators
3.Health facility indicators |
2 Years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Prevalence of polypharmacy |
2 Years |
|
|
Target Sample Size
|
Total Sample Size="93"
Sample Size from India="93"
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)
|
22/08/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
To study Prescription audit in clinically stable patients diagnosed with bipolar depression focusing on the usage of mood stabilizers, antipsychotics and antidepressants. All the patients of bipolar depression attending the OPD of Psychiatry in Rajindra Hospital, Patiala, will be screened according to the inclusion and exclusion criteria. |