Assessing Bone Mineral Density in Schizophrenia: an observational study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Persons diagnosed with Schizophrenia as per ICD-10
- •On active treatment with anti-psychotics with minimum duration of at least 6 months
- •Any gender
- •Age 18 to 50 years
- •Having capacity to give consent / Nominated Representative giving consent
- •Participants who are willing to get the investigations (DEXA scan, hormone studies, routine investigations) done for the study after informed consent.
排除标准
- •Substance abuse or dependence except nicotine and caffeine
- •Psychiatric illness like eating disorders
- •Patient currently pregnant or lactating
- •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.
- •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).
结局指标
主要结局
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
时间窗: At baseline
次要结局
- 1. Association of BMD & endocrine & metabolic parameters(2.Evaluation of BMD in relation to severity of illness, quality of life, physical activity)
研究者
Dr Ajeet Sidana
Government Medical College and Hospital, Sector 32, Chandigarh