CTRI/2025/04/084117招募中2/3 期
Effect of simvastatin as an add on to standard antidepressant therapy in patients with major depressive disorder in indian population: A randomized, double-blind placebo controlled study
All India Institute of Medical Sciences New Delhi1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年5月5日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Reduction in depressive symptoms as assessed by the Hamilton Depression Rating Scale (HAMD-17)
研究概览
简要总结
| This study will use a prospective, randomized, double-blind, placebo-controlled design to investigate the effects of add-on Simvastatin therapy over 6 weeks on patients with major depressive disorder (MDD). The primary aim is to assess changes in depressive symptoms using the Hamilton Depression Rating Scale (HAMD-17). Secondary objectives include evaluating changes in serum IDO and serum BDNF levels, changes in proinflammatory cytokines, and the Montgomery-Åsberg Depression Rating Scale (MADRS), as well as assessing the safety of the simvastatin therapy. Participants clinically diagnosed with major depressive disorder and on stable antidepressant therapy for at least 4 weeks. They will be screened in the psychiatry outpatient department at AIIMS, New Delhi. Eligible participants meeting the inclusion criteria will be randomly assigned to either the treatment group, receiving simvastatin 20 mg, or the placebo group, receiving a matching placebo. Both groups will continue their ongoing antidepressant regimen for 6 weeks. At enrollment, demographic data, depression scores, and antidepressant treatment-related data will be collected. Blood samples will be taken to measure depression-related markers (BDNF and IDO). After 6 weeks of supplementation, all baseline parameters will be reassessed. Changes in depression scores from baseline to post-supplementation will be calculated and presented as mean (SD). Any adverse events during the intervention will be monitored and reported to the corresponding authorities. |
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
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 on a stable dose (no change in dose) of antidepressants for 4 weeks.
- •Patients willing to participate and give consent.
排除标准
- •Patients with comorbid psychiatric or neurological disorders and substance use disorders except nicotine replacement therapy.
- •Use of other lipid-lowering therapies.
- •Significant liver disease (e.g., ALT/AST more than 3 times the upper limit of normal) or liver failure.
- •History of rhabdomyolysis, unexplained muscle pain, weakness, or unexplained creatinine kinase (CK) more than 3 times the upper limit of normal.
- •History of muscle disorders (e.g., rhabdomyolysis, myositis).
- •Severe renal impairment Patients with LDL values less than 80 mg/dl and LDL values more than 190 mg/dl.
- •Patients on immunomodulator therapy.
- •Pregnancy or lactation or expecting to get pregnant during the treatment.
结局指标
主要结局
Reduction in depressive symptoms as assessed by the Hamilton Depression Rating Scale (HAMD-17)
时间窗: At baseline and 6 weeks
次要结局
- Reduction in depression symptoms as assessed by the Montgomery Åsberg Depression Rating Scale (MADRS) after 6 weeks of add-on simvastatin therapy.
研究者
Dr Mokshit Meera Mukund
All India Institute of Medical Sciences, New Delhi
研究点 (1)
Loading locations...
相似试验
尚未招募
2 期
Effect of regimen mentioned in Ashtang Sanghraha followed by women after delivery for normal state after delivery.CTRI/2025/03/082354Komal Prakash Patil100
招募中
3 期
Randomized, Double-Blind, Placebo-Controlled, Multiple-Attack Study with an Open-Label Extension to Evaluate the Efficacy, Safety, Tolerability, and the Consistency of Effect of Atogepant for the Acute Treatment of Migraine (ECLIPSE)Migraine2023-506029-12-00AbbVie Deutschland GmbH & Co. KG755
招募中
3 期
A Phase 3b Study to Evaluate the Duration of Effect of Bimatoprost SR in Participants with Open-Angle Glaucoma or Ocular HypertensionOcular HypertensionOpen-Angle Glaucoma2022-502380-37-00Abbvie Deutschland GmbH & Co. KG167
招募中
3 期
A Study to Evaluate the Efficacy, Safety, and Tolerability of Atogepant for the Preventive Treatment of Menstrual MigraineMenstrual Migraine2024-512946-41-00AbbVie Deutschland GmbH & Co. KG247
尚未招募
不适用
A study to evaluate the efficacy of test regime in lactating females with hair fall.CTRI/2025/07/090485ANVEYA LIVING PRIVATE LIMITED50