A comparative study on efficacy and safety of pioglitazone as add on therapy with standard therapy in patients with depression - A randomized open labelled prospective study.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Improvement in Hamilton depression scores in study group
研究概览
简要总结
This study aimed to assess the safety and efficacy of Pioglitazone in management of depression as an add on therapy to standard therapy in comparison with standard therapy alone. This can pave the way for new promising drug in treating depression with minimal side effects. Patients with depression fulfilling the Inclusion criteria will be included in the study. On enrollment all participants will be assessed clinically by Hamilton depression rating scale and patients with mild to moderate depression of score 10-17 will be included. Baseline investigations including CBC, RFT, LFT, FBS, PPBS, Lipid profile done before start of the study. Participants will be randomized into two groups. Participants in control group will take standard therapy T.Citalopram 10 mg OD. Participants in study group will take pioglitazone as an add on therapy to standard therapy for 12 weeks. Participants will be assessed clinically using HAM-D score after 12 weeks. All ADRs will be noted, analyzed and reported to Regional Pharmacovigilance centre using the CDSCO ADR reporting form.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients with mild to moderate depression diagnosed by DSM 5 criteria with Hamilton Depression score 10-17.Patients with unresolved symptoms of depression with standard dose of antidepressant.
排除标准
- •Patients with severe depression Electroconvulsive therapy within 6 months Patients with substance abuse Pregnant and lactating mothers Patients with liver disease, heart failure, renal impairment.
结局指标
主要结局
Improvement in Hamilton depression scores in study group
时间窗: Baseline, 4 weeks, 8 weeks, 12 weeks.
次要结局
- Any adverse drug event due to Tablet Pioglitazone and Tablet Citalopram(At every visit patient will be assessed for any adverse drug reactions with additional 1 month follow up)
研究者
Dr Divakar A
Government Kilpauk Medical college
