A randomized study of the cost effectiveness and tolerability of escitalopram and desvenlafaxine in treatment of moderate to severe depression
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- reduction of MADRS score to 12 or by 50% from baseline scores and QoL is measured using 12-item short form of the Medical Outcomes Study questionnaire (SF-12)
研究概览
简要总结
Depression is the most common mood disorder affecting the population of all age groups with considerable impact on the quality of life with increased morbidity and mortality, imposing a great burden on the individual, family and society. The increasing prevalence of depression is of global concern regarding the cost of health care, loss of earning thus raising the interest in cost-benefit analysis in treating depression with the available therapies.
Even though depression can be treated by non-pharmacological methods like psychotherapy, electroconvulsive therapy and phototherapy, pharmacological approach remains the mainstay of the treatment. Currently, several classes of effective antidepressants are available such as tricyclic antidepressants (TCAs), selective serotonin reuptake inhibitors (SSRIs), serotonin-noradrenaline reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs) and atypical antidepressants.
SSRIs are the generally preferred drugs as primary option because of their high efficacy, safety and tolerability. Escitalopram (S-enantiomer of citalopram) is one of the most widely prescribed SSRI because of its good tolerability and minimal drug interactive potential. Desvenlafaxine, an SNRI, is one of the most effective antidepressant, particularly for resistant depression, and also claimed to have additional therapeutic advantages. Both the drugs are known to have similar efficacy and few studies have been done in the Indian population to compare the cost-effectiveness and tolerability of these two drugs, hence the present study is taken up.
Objectives of the Study
To evaluate the cost-effectiveness of escitalopram and desvenlafaxine in treatment of moderate to severe depression.
To assess the tolerability and QoL of escitalopram and desvenlafaxine in the study subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Subjects of either gender aged between 18-65 years.
- •â€¢Subjects with first episode or recurrent episode of depression according to (ICD-10) with baseline score >18 and < 40 according to MADRS.
- •â€¢Willingness to give written informed consent and available for follow up.
排除标准
- •â€¢Atypical depression •Postpartum depression •Pregnant women, breast feeding and women planning to conceive.
- •â€¢Subjects with severe depression requiring ECT and with high risk of suicidal tendency.
- •â€¢Co-morbid psychiatric illnesses •Previous history of epilepsy and sexual dysfunction •Serious or uncontrolled medical illness like glaucoma, hypertension, diabetes mellitus, hyperlipidemia, myocardial infarction, hepatic and renal impairment.
- •â€¢Depression secondary to medical illnesses, post traumatic depression.
- •â€¢Known history of allergy to both the study medications.
- •â€¢Participation in any other research study in recent past.
结局指标
主要结局
reduction of MADRS score to 12 or by 50% from baseline scores and QoL is measured using 12-item short form of the Medical Outcomes Study questionnaire (SF-12)
时间窗: baseline, 4week, 8 week, follow up
次要结局
- Remission of scores by 50%(baseline,4 week, 8 week, follow up.)