A single blind randomised controlled trial to determine the relative efficacy and safety of low dose cariprazine vs olanzapine-fluoxitine fixed dose combination in patients with acute bipolar depression-II
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- To compare the therapeutic efficacy of low-dose Cariprazine and OFC in acute
研究概览
简要总结
Bipolar disorder is a complex psychiatric illness characterized by the presence of alternating episodes of mania or hypomania and depression. While both manic and depressive episodes can have significant impact on an individual’s life, depression is a particularly challenging aspect of bipolar disorder. Bipolar depression is associated with high rates of morbidity, disability and suicide. One of the most effective treatment options available for bipolar depression is Olanzapine-Fluoxetine Fixed-dose Combination (OFC) as per the standard international guidelines. However, it causes significant weight gain, and cardio-vascular morbidity which decreases compliance. Effective treatment options for this aspect are urgently needed, which includes the recently US Food and Drug Administration (US-FDA) approved drug for bipolar depression, that is low-dose Cariprazine. The aim of this study will be to compare the efficacy and safety of two drugs i.e., low-dose Cariprazine and OFC in patients with acute Bipolar-II depression It will be a hospitalbased, interventional, comparative and prospective follow-up, single-blind randomized trial (N=140). Patients will be taken from both OPD and IPD of Psychiatry Department of G.M.C. and Rajindra Hospital, Patiala. They will be divided into two groups of 70 each. Group A (low-dose Cariprazine) and Group B (OFC) will Page 13 of 92 be evaluated at baseline, 2 weeks, 4 weeks and 6 weeks and 8 weeks. Primary outcome measures will be therapeutic response on Bipolar Depression Rating Scale (BDRS) and Clinical Global Impressions- Bipolar (CGI-BP) scales and improvement in quality of life on the World Health Organization Quality of Life- Brief version (WHOQoL-Bref). Secondary outcome will be treatment emergent adverse events (TEAEs) including physical parameters of body weight (kg), body mass index (BMI), blood pressure (BP), lab investigations of fasting blood sugar (FBS), fasting lipid profile (FLP) and glycosylated hemoglobin (HbA1c), manic switch on Young‟s Mania Rating Scale (YMRS), extrapyramidal adverse effects on ESRS score and other adverse events on the Indian Pharmacopoeia ADR reporting form. Data will be analyzed by relevant tests wherever applicable at statistically significant p value <0.05.
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
- •Patients in the age group of 18 to 65 years.
- •Patients suffering from acute bipolar-II depression as per ICD-11 criteria.
- •Patients who will be medically stable.
- •Patients who will be accompanied by reliable informants.
- •Patients and informants who give written informed consent and are willing participate in the study.
排除标准
- •Patients who have associated medical illness, which could affect the course of illness e.g., T2DM, hypertension, pulmonary/cardiovascular/renal illnesses.
- •History of substance use disorder in the last six months.
- •Patient on other psychiatric medication which may interfere in assessing treatment response by the principal drug:- a.
- •Mood stabalizers, e.g., Lithium, Divalproex, Carbamazepine, Lamotrigine.
- •Other Antipsychotics, e.g., Quetiapine, Lurasidone, Risperidone, Amisulpiride, etc.
- •Other Antidepressants, e.g., SSRIs other than Fluoxetine, SNRIs and atypical antidepressants.
- •For this purpose, a 2-week washout period for any of the above drugs will be carried out with the permission and written consent of patient and caregiver.
- •Any other co-morbid psychiatric illness.
- •Patients requiring multiple psychotropics (except adjunct medication i.e. BZD/ Propranolol).
- •Pregnant and Breastfeeding females.
- •Patients with Intellectual disability.
- •Patients with history of epilepsy, or other organic/ neurological disorder.
- •Hypersensitivity to low-dose Cariprazine or OFC as applicable.
- •10.Refusal to give written informed consent.
结局指标
主要结局
To compare the therapeutic efficacy of low-dose Cariprazine and OFC in acute
时间窗: Therapeutic efficacy will be determined in the visit one(baseline), week 2, week 4, week 6, week 8
bipolar-II depression
时间窗: Therapeutic efficacy will be determined in the visit one(baseline), week 2, week 4, week 6, week 8
次要结局
- To compare the at-risk metabolic factors in terms of side effect profile due to lowdose Cariprazine an(Therapeutic efficacy will be determined in the visit one(baseline), week 2, week 4, week 6, week 8)
研究者
Dr Avi jindal
Government medical college and Rajindra hospital Patiala