Comparative Efficacy of Antidepressant Augmentation With Amantadine vs Pramipexole vs Quetiapine in Treatment-resistant Unipolar Depression: A Randomized Controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Hamilton Depression Scale scores
研究概览
简要总结
The present study has been designed to compare the efficacy and safety of augmentation of SSRIs with Amantadine vs Pramipexole vs the recommended Quetiapine augmentation in Treatment-Resistant Depression (TRD) and correlate the changes in depression scores with changes in the serum levels of Brain-derived neurotrophic factor (BDNF) and Nerve growth factor (NGF).
The proposed study will be a prospective, randomized, single-blind, controlled clinical trial in patients with TRD and will be conducted over a period of 2 years. The study cohort will comprise 150 patients with unipolar depression clinically diagnosed as TRD, who are currently on Sertraline treatment (dose range = 100-200 mg/day). At baseline, Hamilton Depression Scale (HAM-D 21 item) will be administered to determine the severity of depressive symptoms, Clinical Global Inventory (CGI) will be administered to determine the baseline severity of the illness. Serum BDNF, and NGF will be estimated by ELISA using commercially available Human ELISA kit. The sample will be divided into 3 equal treatment groups by block randomization technique, each group comprising of 50 patients.
Group 1 will receive Amantadine 200 mg/day (in two divided doses) augmentation to the ongoing Sertraline treatment. Group 2 will receive Pramipexole 0.375 mg/day (in three divided doses) augmentation to the ongoing Sertraline treatment. Group 3 will serve as the control arm and receive the recommended Quetiapine XR 100 mg/day augmentation to the ongoing Sertraline treatment.
The study cohort will be reassessed for the changes in HAM-D scores, CGI severity scores, Improvement score and Efficacy index, at 4 and 8 weeks follow up. The changes in Serum BDNF, and NGF will be estimated at the end of 8 weeks, to correlate with the change in severity of depressive symptoms. All the participants will be evaluated for any untoward side effects in a prescribed format for the Pharmacovigilance program of India (PVPI). The patient in either of the treatment arms, who are not responding to treatment or relapsing with aggravation of depressive symptoms will be switched on to Venlafaxine treatment or Electro-convulsive therapy (ECT) as decided by the treating team.
详细描述
STUDY OBJECTIVES:
Primary Objective
• To compare the change in the severity of symptoms of depression in terms of change in HAM-D scores between the treatment groups over 8 weeks.
Secondary Objective
- To compare the change in CGI scores between the treatment groups over 8 weeks.
- To evaluate the change in serum BDNF, serum NGF levels between the treatment groups over 8 weeks.
- To detect adverse drug reactions (if any) (prescribed format for Pharmacovigilance program of India PVPI)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcome assessor will remain blind to the treatment allocation
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with unipolar depression clinically diagnosed as TRD, who are currently on Sertraline treatment (dose range = 100-200 mg/day)
- •Patients aged 18-60 years of either sex
排除标准
- •Patients with Bipolar affective disorder
- •Patient with TRD on antidepressants other than Sertraline
- •History of psychoactive substance abuse or dependence
- •Co-morbid psychiatric, major medical, or neurological disorders
- •History of organicity or significant head injury
- •Pregnant and lactating women
研究组 & 干预措施
Quetiapine group
Quetiapine XR 100 mg/day augmentation to the ongoing Sertraline treatment.
干预措施: Quetiapine (Drug)
Amantadine group
Amantadine 200 mg/day (in two divided doses) augmentation to the ongoing Sertraline treatment
干预措施: Amantadine (Drug)
Pramipexole group
Pramipexole 0.375 mg/day (in three divided doses) augmentation to the ongoing Sertraline treatment
干预措施: Pramipexole (Drug)
结局指标
主要结局
Hamilton Depression Scale scores
时间窗: 8 weeks
Change in Hamilton Depression Scale scores 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression Higher scores indicating higher severity of depression
次要结局
- Rescue Medications(8 weeks)
- Clinical Global Impression scores(8 weeks)
- Serum Brain Derived Neurotrophic Factor(8 weeks)
- Serum Nerve Growth Factor(8 week)
研究者
BISWA RANJAN MISHRA
Additional Professor, Department of Psychiatry
All India Institute of Medical Sciences, Bhubaneswar