Fase III Study to Evaluate the Efficacy of LABCAT TCJUSS in Patients With Depressive Episode
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- HAM-D SCORE REDUCTION
研究概览
简要总结
Evaluate the therapeutic effects of Escitalopram versus an association of Escitalopram + Trichilia catigua Dry Extract (LABCAT TCJUSS) in the average alteration on depression score measured by the Hamilton Scale (HAM-D).
详细描述
Evaluate the therapeutic effects of Escitalopram versus an association of Escitalopram + LABCAT TCJUSS in the following aspects:
- Alteration on the average score of anhedonia symptoms through the Shaps-C Scale;
- Alteration of average scores of Global Clinical Impression carried out by the investigator (CGI-S e CGI-I);
- Average scores of the Patient Global Evaluation
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects from both sexes aged between 18 and 65 years;
- •Patient diagnosed with mild depression episode confirmed by psychiatric and psychometric evaluation, presenting basal scores above 08 and below 24 measured by the Hamilton Rating Scale (HAM-D);
- •Capable of understanding the nature and objective of the study, including risks and adverse effects and intended to cooperate with the researcher and act in accordance with the requirements of the entire protocol, which comes to be confirmed by signing the informed consent.
排除标准
- •Have a known hypersensitivity to Trichilia catigua or history of serious adverse reactions;
- •Shows risk of suicide, assault, murder or moral exposure;
- •Clinical history of bleeding disorders;
- •Drug addiction, including alcohol;
- •Known or suspected neoplasia;
- •Knowledge positive test result for the human immunodeficiency virus;
- •Patient not willing to adhere to the procedures of the Protocol;
- •For women, can not be pregnant or nursing and must be in use of a contraception method during the participation in the study;
- •Patients using other drugs with sedative or antidepressant action, which can not be suspended for 15 days (wash out);
- •Diabetics;
- •Hyperthyroidism;
- •Participation in any experimental study or use of any experimental drug three months before the start of this study;
- •Has any condition which the investigator deems relevant to the non-participation of the study.
研究组 & 干预措施
Escitalopram + LABCAT TCJUSS
Escitalopram 10mg + LABCAT TCJUSS 1000 mg daily (two 250mg capsules in the morning + 2 capsules of 250 mg at night);
干预措施: Escitalopram 10mg (Drug)
Escitalopram + LABCAT TCJUSS
Escitalopram 10mg + LABCAT TCJUSS 1000 mg daily (two 250mg capsules in the morning + 2 capsules of 250 mg at night);
干预措施: LABCAT TCJUSS (Drug)
Escitalopram + LABCAT TCJUSS placebo
Escitalopram 10mg + LABCAT TCJUSS placebo daily (2 capsules in the morning + 2 capsules at night);
干预措施: Escitalopram 10mg (Drug)
Escitalopram + LABCAT TCJUSS placebo
Escitalopram 10mg + LABCAT TCJUSS placebo daily (2 capsules in the morning + 2 capsules at night);
干预措施: LABCAT TCJUSS Placebo (Drug)
Escitalopram Placebo + LABCAT TCJUSS
Escitalopram Placebo + LABCAT TCJUSS 1000 mg daily (2 capsules in the morning + 2 capsules at night).
干预措施: LABCAT TCJUSS (Drug)
Escitalopram Placebo + LABCAT TCJUSS
Escitalopram Placebo + LABCAT TCJUSS 1000 mg daily (2 capsules in the morning + 2 capsules at night).
干预措施: Escitalopram Placebo (Drug)
结局指标
主要结局
HAM-D SCORE REDUCTION
时间窗: WEEKS 2 (Visit 2), 4 (Visit 3), 8 (Visit 4) and 10 (Visit 5)
A comparison will be performed between groups in mean reduction in the HAM-D score between baseline (V1-D1) and at weeks 2 (V2), 4 (V3), 8 (V4) and 10 (V5) treatment, following the primary and secondary described outcomes.
次要结局
- Evaluation of symptoms of anhedonia by the change in mean score of Shaps-C scale of pleasure(WEEKS 2 (Visit 2), 4 (Visit 3), 8 (Visit 4) and 10 (Visit 5))
- Change in mean scores of Clinical Global Impression performed by the investigator (CGI-I - Improvement)(WEEKS 2 (Visit 2), 4 (Visit 3), 8 (Visit 4) and 10 (Visit 5))
- Change in mean scores of Clinical Global Impression performed by the investigator (CGI-S - Severity)(WEEKS 2 (Visit 2), 4 (Visit 3), 8 (Visit 4) and 10 (Visit 5))
- Change in mean scores of Global Patient Evaluation scale(WEEKS 2 (Visit 2), 4 (Visit 3), 8 (Visit 4) and 10 (Visit 5))
- Change in mean scores of the of Arizona Sexual Experiences scale (ASEX)(WEEKS 2 (Visit 2), 4 (Visit 3), 8 (Visit 4) and 10 (Visit 5))