Phase III Placebo-controlled, Randomised, Single-centre, Double-blind Study of the Antidepressant Efficacy of a Combination Herbal Drug Preparation
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- HAM-D 21
研究概览
简要总结
The efficacy and tolerability of Neurapas® balance was compared against placebo in this single-centre, controlled, double-blind study in patients with a mild depressive episode.
After a one-week placebo run-in phase to exclude placebo responders, patients were given the study medication (Neurapas® balance or placebo) for 6 weeks in a dose of 3 x 2 tablets daily.
The improvement in symptoms of depression was assessed on the basis of the internationally established Hamilton Depression Scale 21. The Self-Rating Depression Scale (SDS), the Hamilton Anxiety Scale (HAM-A), the Clinical Global Impressions (CGI), Quality of Life questionnaire (SF-36) according to Bullinger (German version) and a Sleep questionnaire (SQ) were used as further efficacy criteria.
详细描述
The efficacy and tolerability of Neurapas® balance was compared against placebo in this single-centre, controlled, double-blind study in patients with a mild depressive episode according to ICD 10, F32.0 and F33.0.
After a one-week, placebo run-in phase to exclude placebo responders, patients were given the study medication (Neurapas® balance or placebo) for 6 weeks in a dose of 3 x 2 tablets daily. The study was conducted in accordance with the relevant requirements of the German Medicines Act (AMG), the Declaration of Helsinki (48th General Assembly, Sommerset West, Rep. of South Africa, October 1996) and ICH GCP guidelines.
The improvement in symptoms of depression was assessed on the basis of the internationally established Hamilton Depression Scale 21 (primary efficacy criterion). The Self-Rating Depression Scale (SDS), the Hamilton Anxiety Scale (HAM-A), the Clinical Global Impressions (CGI), Quality of Life questionnaire (SF-36) according to Bullinger (German version) and a Sleep questionnaire (SQ) were used as secondary efficacy criteria.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Depressive symptoms of mild intensity, as defined in the International Classification of Mental Disorders (ICD 10), codes F32.0 (mild depressive episode) and F33.0 (recurrent depressive disorder, current episode mild)
- •SDS Index between 51 and 59 (this criterion was declared null and void on 21.02.02 in the 2nd Amendment)
- •HAM-D21 scores between 10 and 17
- •Between 18 and 70 years of age
- •Duration of depression: not less than 4 weeks and not longer than 2 years
- •Signed informed consent to take part in the clinical study after verbal and written information.
排除标准
- 未提供
研究组 & 干预措施
Verum
Neurapas balance, film-coated tablet
干预措施: Neurapas® balance (Herbal combination out of hypericum, valerian, passionflower) (Drug)
Placebo
干预措施: film-coated sugar-pill (Drug)
结局指标
主要结局
HAM-D 21
时间窗: Visit 1 (Start of medication), Visit 2 (End of run-in phase), Visit 4 (after 2 weeks treatment), Visit 6 (after 4 weeks treatment), Visit 8 (End of Study)
次要结局
- Self-Rating Depression Scale (SDS)(V1, V2, V4, V6, V8)
- HAMILTON Anxiety Scale (HAM-A)(V2, V4, V6, V8)
- Clinical Global Impressions (CGI)(V2, V8)
- BULLINGER Quality of Life questionnaire (SF-36)(V2, V6, V8)
- Sleep questionnaire (SQ)(V2, V6, V8)