Minocycline as an adjunctive therapy in patients with bipolar mania: A randomized double blind placebo controlled study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Effectiveness of Tab. Minocycline (200mg/day) as an adjunctive therapy assessed by YMRS BPRS and CGI scores in patients with bipolar mania.
研究概览
简要总结
As an inhibitor of microglial activation, Minocycline has anti-inflammatory, antioxidant, and antiapoptotic properties, and can modulate glutamate-induced excitotoxicity and neuroprotective effects. These pathways have all been implicated in the causation of mood disorders. Other anti-inflammatory drugs such as Aspirin, Celecoxib, N-acetyl cystiene, Omega3 fatty acids and Pioglitazone has evidence of effectiveness in bipolar depression or mixed episopdes.
Also Minocycline as an anti-inflammatory and neuroprotective drug have already shown improvement as an adjunctive treatment in schizophrenia, autism, bipolar depression, along with other neuropsychiatric conditions. Nevertheless, there is only one preclinical study showing effectiveness of Minocycline in bipolar mania and no clinical studies suggesting the same.
Therefore we want to use Minocycline as a new adjunctive treatment modality in bipolar mania due to its peculiar properties.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Male
入选标准
- •Inclusion criteria for group 1 (Minocycline) and Group 2 (Placebo)
- •Male inpatients satisfying the ICD 10-DCR[1993] criteria of Bipolar affective disorder, current episode mania with YMRS score of >
- •2.Age group of 18-50 years.
- •3.Drug naive or drug free patients for minimum 2 weeks for mood stabilisers/antipsychotics and 4 weeks for depot antipsychotics.
- •4.Those who give informed consent for participating in the study.
排除标准
- •Exclusion criteria for group 1 (Minocycline) and Group 2 (Placebo) 1.Any other major co-morbid psychiatric diagnosis and substance dependence excluding nicotine & caffeine.
- •2.Significant current/ past medical or neurological illness including severe hepatic disease and history of severe head injury .
- •3.Known hypersensitivity to Tab.
- •Minocycline or any of its components.
- •4.Patients who had received ECT in last 6 months.
结局指标
主要结局
Effectiveness of Tab. Minocycline (200mg/day) as an adjunctive therapy assessed by YMRS BPRS and CGI scores in patients with bipolar mania.
时间窗: Baseline, 2 weeks and 6 weeks
次要结局
- Change in the levels of IL-1β-converting enzyme, iNOS,and Bcl-2 in patients receiving adjunctive Tab. Minocycline (200 mg/day).(Baseline, 2 weeks and 6 weeks)