| CTRI Number |
CTRI/2023/11/059495 [Registered on: 03/11/2023] Trial Registered Prospectively |
| Last Modified On: |
02/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To find out the prevalence of Anxiety, Depressive symptoms and Substance use in persons with Schizophrenia. |
|
Scientific Title of Study
|
Prevalence of Anxiety, Depressive Symptoms and Substance Use in persons with Schizophrenia |
| 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 Prabhas Pandey |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
Government Medical College And Hospital Chandigarh |
| Address |
Department of Psychiatry,
Block-D, Level-V
Government Medical College and Hospital,
Sector-32, Chandigarh (UT)
Chandigarh
CHANDIGARH
160030
India |
| Phone |
7898021558 |
| Fax |
|
| Email |
pandey.prabhas@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajeet Sidana |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital, Sector-32, Chandigarh |
| Address |
Department of Psychiatry,
Block-D, Level-V
Government Medical College and Hospital,
Sector-32, Chandigarh (UT)
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9056422679 |
| Fax |
0172-2609360 |
| Email |
ajeetsidana@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajeet Sidana |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital, Sector-32, Chandigarh |
| Address |
Department of Psychiatry,
Block-D, Level-V
Government Medical College and Hospital,
Sector-32, Chandigarh (UT)
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9056422679 |
| Fax |
0172-2609360 |
| Email |
ajeetsidana@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Hospital, Sector 32, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital |
| Address |
Sector 32, Chandigarh |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prabhas Pandey |
IPD/ Psychiatry Ward |
LEVEL 3, Government Medical College and Hospital, South Campus, Sector 48, Chandigarh
Chandigarh
CHANDIGARH |
7898021558
pandey.prabhas@yahoo.com |
| Dr Prabhas Pandey |
Mental Health Institute |
OPD Room, Sector 32 C Chandigarh
Chandigarh
CHANDIGARH |
7898021558
pandey.prabhas@yahoo.com |
| Dr Prabhas Pandey |
OPD |
Room No 4212, Level 4, B Block, Government Medical College and Hospital,
Sector 32, Chandigarh
Chandigarh
CHANDIGARH |
7898021558
pandey.prabhas@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, GMCH Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F20||Schizophrenia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosis of Schizophrenia according to ICD-11.
2. Age group 18- 60 years.
3. Any gender.
4. Duration of Illness less than 5
|
|
| ExclusionCriteria |
| Details |
1. Individuals with intellectual disability, uncooperative and violent patient.
2. Patient’s not giving consent.
3. Actively Suicidal patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the Prevalence of Anxiety, Depressive symptoms and Substance use in persons with Schizophrenia. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the frequency & severity of Anxiety, Depressive symptoms & Substance Use in persons with Schizophrenia. |
Baseline |
| To find correlation among Anxiety, Depressive symptoms & Substance Use with severity of Schizophrenia. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="170"
Sample Size from India="170"
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)
|
12/11/2023 |
| 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)
|
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
|
A total of 170 consecutive patients diagnosed with Schizophrenia as per ICD-11 coming to follow up in OPD and admitted in IPD will be evaluated based upon the inclusion and exclusion criteria mentioned above. Patients will be enrolled in the study after obtaining informed consent from the patient. Vitals with Routine Investigations (CBC, SERFT, LFT, LIPID PROFILE, FBS) along with ECG will be done at baseline. PANSS will be applied to all those individuals AIMS Scale will be applied for EPS In all patients HAM-A will be applied for Anxiety symptoms HAM-D will be applied for Depressive symptoms ASSIT will be applied for Substance Use Data will be compiled on excel sheet and will be analysed using SPSS. After assessment of these symptoms, same will be communicated to the Treating Psychiatrist. |