NACOS - The Effect of N-acetylcystein for Depressive Symptoms in Patients Suffering From Bipolar Depression - A Double Blind Randomized Placebo-controlled Trial With Follow up
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The total score of MADRS
研究概览
简要总结
This trial investigate add-on treatment with 3 g NAC vs. placebo in 20 weeks in patients suffering from bipolar depression. The primary outcome is MADRS-score, and the secondary outcomes are other psychometric evaluations oxidative stress biomarkers in urine.
详细描述
Bipolar depression can be extremely invalidating because of the depressive symptoms that results in decreased social functioning which reduces the quality of life. Bipolar depression is associated with three times longer duration of disorder period compared to mania. This emphasizes the importance of optimal treatment opportunities for this particular group.
Psychological treatments are often based on effective maintenance therapy, with limited evidence of acute bipolar depression. The effect of lithium in the acute phase of depression is low, and the use of valproate is still unclear in bipolar depression. Lamotrigine and other antipsychotics, has some efficacy in bipolar depression but have considerable tolerance issue. The most effective treatment is quetiapine and quetiapine XR, but this treatment is associated with side effects such as sedation, weight gain and dyslipidemia.
Individuals suffering from bipolar depression has a recognisable dysregulated oxidative mechanisms. Evidence indicates that GSH, which is the central antioxidant in brain are vulnerable to degradation. However, N-acetylcystine (NAC) improves the L-cysteine supply and leads to increase GSH in the brain.
A clinical randomized controlled study with 75 patients, showed a significant decreases in the primary outcome measure (MADRS-score) compared to the control group. Furthermore, were the general health status and function improved in NAC group.
This double-blinded randomized placebo controlled trial is conducted, to demonstrate the efficacy of NAC on depressive symptoms in patients suffering from bipolar depression, and examine the effect of add-on treatment of NAC on the level of oxidative stress, quality of life and functioning.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients that meet the DSM-5 criteria of bipolar disorder type 1 or 2 (296-41-296.56 or 296.89) with at least one documented illness episode in the past six months, have had depressive symptoms at least 4 weeks before inclusion, MADRS ≥ 18 at baseline, have been sick at least 4 weeks, between 18-64 years, fertile women with a negative pregnant test at baseline, turtle women using safe contraception in the study period, and patients who have given informed consent.
排除标准
- •Pregnant women, patients wishing pregnancy during the frame of the study, current suicidality, patients that have an intake of more than 500 mg NAC, 200 μm selenium, or 500 IU of vitamin E every day is excluded. Patients who are hypersensitive to histamine, patients who have had ECT-treatment within the last 4 weeks. Patients with recent bleeding in respiratory, asthma, epilepsy or allergy towards NAC. People who cannot speak or understand the Danish language, or have not give or withdrawn informed consent. If patients change diagnosis during the study, and the primary diagnosis is not bipolar affective disorder is the participant excluded.
研究组 & 干预措施
NAC group
Receiving N-acetylcysteine as add-on treatment
干预措施: N-acetylcysteine (Drug)
Placebo group
Receiving placebo as add-on treatment
干预措施: Placebo (Drug)
结局指标
主要结局
The total score of MADRS
时间窗: Change from baseline MADRS-score at 20 weeks
次要结局
- The total score of MES(Change from baseline MES-score at 20 weeks)
- The total score of YMRS(Change from baseline YMRS-score at 20 weeks)
- The total score of WHO-5(Change from baseline WHO-5-score at 20 weeks)
- The total score of GAF-S(Change from baseline GAF-S-score at 20 weeks)
- The total score of GAF-F(Change from baseline GAF-F-score at 20 weeks)
- The measurement of oxidative stress in biological material (urine)(Change from baseline oxidative stress measurement at 20 weeks)
研究者
Connie Thuree Nielsen, consultant, MD, ph.d
Consultant, MD, Ph.D
Region Syddanmark