Efficacy of Individualized Homeopathic Treatment for Moderate to Severe Depression in Peri- and Postmenopausal Women: a Randomized Placebo-controlled, Double-blind, Double-dummy, Study Protocol
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 133
- 试验地点
- 1
- 主要终点
- Change From Baseline in 17-item Hamilton Rating Scale for Depression at 6 Weeks.
研究概览
简要总结
The aim of this study was to determine whether individualized homeopathic treatment and fluoxetine are more efficient than placebo for moderate to severe depression in peri- and postmenopausal women.
详细描述
Perimenopausal period is characterized by an increased risk of depressive symptoms. Major depression is one of the most disabling medical conditions worldwide. At present, it is becoming more difficult to prove that antidepressants actually work better than placebo in clinical trials.Use of homeopathy to treat depression is widespread, but there is a lack of clinical trails about its efficacy in depression in peri- and postmenopausal women. Previous trials suggest that individualized homeopathic treatments improve depression in general population. The purpose of this study was to determine whether individualized homeopathic treatment and fluoxetine are more efficient than placebo for moderate depression in peri- and postmenopausal women.
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
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Major depression according to DSM-IV
- •Moderate to severe depression according to 17-item Hamilton Rating Scale for Depression (14-24 score)
- •No current use of homeopathic treatment for depression or antidepressants or anxiolytic drugs 3 months prior to study entry
- •Not be currently taking psychotherapy for at least 3 months before study entry
- •Early transition to menopause defined by a change in cycle length of 7 days or longer in either direction from the participant´s own baseline for at least 2 cycles
- •Late transition to menopause defined as 3 to 11 months of amenorrhea
- •Postmenopausal stage defined by 12 months or more of amenorrhea
- •Capability and willingness to give informed consent and to comply with the study procedures
排除标准
- •Pregnancy or breastfeeding
- •Other psychiatric disorders different from moderate to severe depression (severe depression, schizophrenia, psychotic disorders, bipolar affective disorders, suicide attempt)
- •Alcohol or other substance abuse
- •Known allergy to fluoxetine
- •Cancer or hepatic diseases
研究组 & 干预措施
Individualized homeopathic treatment
Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.
干预措施: Individualized homeopathic treatment (Drug)
Fluoxetine
Selective serotonin reuptake inhibitor.
干预措施: Fluoxetine (Drug)
Placebo
Fluoxetine placebo plus individualized homeopathic placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in 17-item Hamilton Rating Scale for Depression at 6 Weeks.
时间窗: Baseline and 6 weeks
17-item Hamilton Rating Scale for Depression (HRSD) is a well-known standardized scale used worldwide to assess severity of depression. Score ranges from 0 (no depression) up to 52 (maximum depression severity). A total score in HRSD was assessed at baseline and after six weeks of treatment. For this study the change was calculated as the later time point (total score in 17- HRSD at 6 weeks) minus the earlier time point (total score at baseline). A score \< or = 7 is considered normal, 7 - 13 (mild depression), 14 - 24 (moderate to severe depression), \> 24 (severe depression).
次要结局
- Change From Baseline in Beck Depression Inventory at 6 Weeks.(Baseline and 6 weeks)
- Responder Rates at 6 Weeks.(6 weeks)
- Change From Baseline in Greene´s Scale at 6 Weeks.(Baseline and 6 weeks)
- Remission Rates at 6 Weeks(6 weeks)
研究者
Emma del Carmen Macías-Cortés, MD, PhD
MD, PhD
Hospital Juarez de Mexico