A single blind randomized controlled trial to determine the efficacy and safety of metformin versus dapagliflozin on weight gain in patients of bipolar-ii depression treated with olanzapine-fluoxetine combination
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- To estimate physical parameters including weight, body mass index, waist circumference and blood pressure in patients on antipsychotics and to compare lab investigations including fasting blood sugar, fasting lipid profile and glycated hemoglobin.
研究概览
简要总结
This hospital-based, interventional, comparative and prospective follow-up, single-blind randomized trial will be conducted in patients on antipsychotic use. The aim of this study will be to compare the efficacy and safety of two drugs i.e., metformin and dapagliflozin on weight gain in patients of Bipolar II depression treated with olanzapine–fluoxetine combination.Patients with depressive symptoms visiting outpatient department and/or admitted in inpatient department of psychiatry department will be screened for bipolar disorder using mood disorder questionnaire. Those patients who score >7 on mood disorder questionnaire will be assessed further using young mania rating scale to rule out mania. Patients who score ≤ 12 on young mania rating scale will be interviewed and diagnosed bipolar-II depression as per ICD-11 criteria. Severity of bipolar-II depression will be assessed using bipolar depression rating scale score and clinical global impression – bipolar illness score. Quality of life will be assessed using world health organization quality of life brief version score. These patients will then be screened according to the inclusion and exclusion criteria after recording the relevant physical parameters and lab investigations. Patients put on olanzapine-fluoxetine combination with or without adjunct medication for sleep/anxiety e.g. benzodiazepines, propranolol etc. and developing olanzapine-fluoxetine combination induced weight gain (defined as ≥ 5% weight gain within one month of initiating olanzapine-fluoxetine combination) will be considered eligible. To establish causality, Naranjo’s causality scale will be employed. A written informed consent will be taken. Eligible participants will undergo detailed assessment as per predesigned psychiatric proforma which will assess the socio-demographic profile, illness related details including seasonality, physical parameters including weight, body mass index, waist circumference, blood pressure and lab investigations including fasting lipid profile, fasting blood sugar, haemoglobin A1c etc. Patients will then be randomly allocated into two groups of 62 patients each. Group A will be given olanzapine-fluoxetine combination plus tablet metformin 1000 mg daily for a period for 24 weeks. Group B will be given olanzapine-fluoxetine combination plus tablet dapagliflozin 10 mg daily for a period for 24 weeks. Enrolled patients of two groups will be followed-up and the observations will be recorded at 0 week, 4 weeks, 12 weeks and 24 weeks after initiating weight lowering drugs. Data will be kept strictly confidential. Changes in the parameters of primary and secondary outcomes at the time of visit will be noted and will be subjected to appropriate statistical analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients in the age group of 18 to 65 years.
- •2.Patients suffering from Bipolar-2 depression as per ICD-11 criteria.
- •3.Patients who will be medically stable.
- •4.Patients who will be accompanied by reliable informants.
- •5.Patients who develop Olanzapine-fluoxetine combination induced weight gain as established by Naranjo’s causality scale.
- •6.Patients and informants who give written informed consent and are willing participate in the study and take Tab Metformin and Tab Dapagliflozin as weight loss agents for Bipolar-2 depression.
排除标准
- •1.Patients who have associated medical illness, which could affect the course of illness eg.
- •Type 2 diabetes mellitus, hypertension, pulmonary/cardiovascular/renal/thyroid illnesses.
- •2.History of substance use disorder in the last six months.
- •3.Patient on other psychiatric medication known to increase weight.
- •A.Mood stabalizers: Lithium, Divalproex B.Antipsychotics: Quetiapine, Clozapine, Risperidone.
- •4.Any other co-morbid psychiatric illness.
- •5.Patients requiring multiple psychotropics (except adjunct medication i.e. Benzodiazepines/ Propranolol).
- •6.Pregnant and Breastfeeding females.
- •7.Intellectual disability patients.
- •Patients with history of epilepsy, or other organic disorder.
- •8.Contraindication to use of Metformin e.g. Hypersensitivity etc.
- •9.Contraindication to use of Dapagliflozin e.g. Hypersensitivity, Urinary tract infections (UTIs) etc.
- •10.Refusal to give written informed consent.
结局指标
主要结局
To estimate physical parameters including weight, body mass index, waist circumference and blood pressure in patients on antipsychotics and to compare lab investigations including fasting blood sugar, fasting lipid profile and glycated hemoglobin.
时间窗: outcome will be assessed in four readings at baseline, 4 weeks, 12 weeks and 24 weeks
次要结局
- To compare illness severity by bipolar depression rating scale score and clinical global impression – bipolar illness score, Quality of life on world health organization quality of life brief version score and adverse events on adverse drug reaction scale.
研究者
Sahil Singla
Government Medical College, Patiala