| CTRI Number |
CTRI/2024/12/078713 [Registered on: 30/12/2024] Trial Registered Prospectively |
| Last Modified On: |
27/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Schizophrenia and bone mineral density |
|
Scientific Title of Study
|
Assessing Bone Mineral Density in Schizophrenia: an 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 |
Dr Ajeet Sidana |
| Designation |
Professor and head |
| Affiliation |
Government Medical College and Hospital, Sector 32, Chandigarh |
| Address |
Department of Psychiatry, Level 5, D block, Government Medical College and Hospital, Sector 32
Chandigarh
CHANDIGARH
160032
India |
| Phone |
9056422679 |
| Fax |
0172-2609360 |
| Email |
ajeetsidana@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajeet Sidana |
| Designation |
Professor and head |
| Affiliation |
Government Medical College and Hospital, Sector 32, Chandigarh |
| Address |
Department of Psychiatry, Level 5, D block, Government Medical College and Hospital, Sector 32
CHANDIGARH
160032
India |
| Phone |
9056422679 |
| Fax |
0172-2609360 |
| Email |
ajeetsidana@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajeet Sidana |
| Designation |
Professor and head |
| Affiliation |
Government Medical College and Hospital, Sector 32, Chandigarh |
| Address |
Department of Psychiatry, Level 5, D block, Government Medical College and Hospital, Sector 32
CHANDIGARH
160032
India |
| Phone |
9056422679 |
| Fax |
0172-2609360 |
| Email |
ajeetsidana@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Hospital, Sector 32, Chandigarh, 160032, India |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital |
| Address |
Sector 32, Chandigarh, 160032, 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 Ajeet Sidana |
Govenment Medical College and Hospital |
Psychiatry OPD, Room no 4212, Level 4, D block, Govenment Medical College and Hospital
Chandigarh
CHANDIGARH |
9056422679
ajeetsidana@hotmail.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 |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Persons diagnosed with Schizophrenia as per ICD-10
2. On active treatment with anti-psychotics with minimum duration of at least 6 months
3. Any gender
4. Age 18 to 50 years
5. Having capacity to give consent / Nominated Representative giving consent
6. Participants who are willing to get the investigations (DEXA scan, hormone studies, routine investigations) done for the study after informed consent |
|
| ExclusionCriteria |
| Details |
1. Substance abuse or dependence except nicotine and caffeine
2. Psychiatric illness like eating disorders
3. Patient currently pregnant or lactating
4. Known cases of Bone metabolism diseases, electrolyte imbalance, renal function impairment, pituitary tumor, parathyroid diseases, hyperthyroidism, metabolic bone disorders, bone tumors, Paget’s disease and osteogenesis imperfecta.
5. Co-medications known to affect Bone Mineral Density (e.g. drugs for osteoporosis treatment such as alendronate, parathyroid hormone, estrogens, selective estrogen receptor modulators, bisphosphonates, and calcitonin, heparin, and glucocorticoids). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Association between Schizophrenia and BMD based upon the type and number of drug i.e. (i.) FGA vs SGA (First generation antipsychotics vs Second generation antipsychotics); (ii.) Prolactin Sparing vs Prolactin raising APD; (iii.) Single APD vs multiple APDs and Duration of illness and on treatment for a) Less than 2 years b) 2 years to 9 years c) More than 10 years |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Association of BMD & endocrine & metabolic parameters
2.Evaluation of BMD in relation to severity of illness, quality of life, physical activity
3. Association of BMD between quality of life & disability with positive & negative symptoms of schizophrenia.
4.Association of BMD with bone health promoting nutraceuticals in the form of vitamin D & Calcium supplementation in past 6 months |
At baseline |
|
|
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)
|
08/01/2025 |
| 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="0"
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
|
In this research, the association between schizophrenia and BMD will be evaluated using a combination of DEXA results and scales via statistical methods. PANSS will be employed to assess the severity of schizophrenia symptoms, while the IPAQ will gauge physical activity levels. IDEAS will assess disability, and the WHOQOL-BREF will evaluate overall quality of life. Additionally, the UKU-SERS will be used to monitor medication side effects. Statistical analyses, including correlation and regression techniques, will be applied to determine the relationships among these variables and their impact on BMD, aiming to provide a comprehensive understanding of how these factors will interrelate in the context of schizophrenia. Outcome measurement method 1. Clinical records of the patient 2. Blood investigations 3. Radiological investigation 4. Structured/semi-structured interviews 5. Relevant questionnaires/scales Clinical details: Socio-demographic and clinical pro-forma, General physical parameters: Weight, height, BMI Severity of illness: Positive and Negative Syndrome Scale (PANSS) Physical activity: International Physical Activity Questionnaire (IPAQ) Side effects: UKU Side Effects Rating Scale (UKUSERS) Severity of disability: Indian Disability Evaluation And Assessment Scale (IDEAS) Quality of life: WHOQoL-BREF Bone mineral density: DEXA-Scan (Iliac crest) Biochemical parameters: Serum creatinine, Serum calcium, Serum phosphorus, Enzymes: serum glutamicpyruvic transaminase, serum glutamicoxaloacetic transaminase, alkaline phosphatase Hormonal assay Testosterone, LH, FSH, prolactin, 25hydroxy-vitamin D3, T3,T4,TSH , parathyroid hormone, cortisol Haematological parameters: Complete blood count |