Agomelatine Treatment of Major Depressive Episodes in the Course of Schizophrenic Psychoses (AGOPSYCH)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Antidepressive efficacy
研究概览
简要总结
Major depressive episodes (MDEs) occur frequently during the course of psychotic disorders, and several antidepressive agents have been successfully applied. The new melatonergic antidepressant agomelatine (AGO) appears promising for the treatment of MDEs in schizophrenia for several reasons. The investigators plan to test the efficacy and tolerability of AGO for antidepressive treatment in schizophrenia. For this task, the investigators plan to enrol 27 schizophrenic patients into an open, single-armed, prospective clinical trial with agomelatine.
详细描述
Major depressive episodes (MDEs) occur frequently during the course of psychotic disorders, and several antidepressive agents have been successfully applied. The new melatonergic antidepressant agomelatine (AGO) appears promising for the treatment of MDEs in schizophrenia for several reasons: 1. AGO provides a unique pharmacological profile by combining antidepressive potency, sleep regulation and enhancement of frontocortical dopaminergic activity by 5-HT-2C-blockade. 2. AGO might exert favourable effects on cognition. 3. While pharmacokinetic interactions are generally possible, major influences on antipsychotic substances are unlikely due to metabolism by cytochrome isoenzymes CYP1A2 and CYP2C9/19. 4. AGO is characterized by a favourable range of adverse events (AE) which do not overlap with typical antipsychotic AEs such as weight gain and sexual dysfunction. Thus, the risk of additive effects seems to be small. The investigators plan to enroll 27 schizophrenic patients into an open, single-armed, prospective clinical trial with agomelatine. As predefined primary and secondary endpoints, we are going to investigate whether AGO is able to improve MDE severity, sleep quality, general and psychosocial functioning as well as cognitive function in schizophrenia without detrimental effects on the psychotic syndrome. Moreover, we intend to monitor for pharmacokinetic interactions. The results obtained will allow designing future randomized and controlled clinical trials in order to improve the range of therapeutic options for affective and cognitive deficits in schizophrenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 60 years.
- •Presence of an MDE according to ICD-10 criteria (HAMD17 ≥ 18 or CDSS-Score ≥ 8 points).
- •Lifetime diagnosis of schizophrenia-spectrum disorder according to ICD-10 (F 20, F22, F23, F25).
- •Partial remission of psychotic positive symptoms (PANSS positive subscore ≤ 15 points).
- •Stable antipsychotic medication for at least 2 weeks (tolerable quantitative changes of daily dosage ≤ 25%).
- •The patient is able to give an informed consent. In case of legal guardianship, the custodian will have to agree to the patient's participation.
排除标准
- •Contraindications against AGO treatment
- •Insufficient contraception in women of childbearing potential when sexually active.
- •Gravidity or breastfeeding.
- •Addiction to alcohol
- •Current abuse of THC and other illegal substances according to ICD-10
研究组 & 干预措施
Treatment
Open-label treatment with agomelatine 25 mg/day (or 50 mg/day after week 3).
干预措施: agomelatine (Drug)
结局指标
主要结局
Antidepressive efficacy
时间窗: 6 weeks
Comparison of MDE severity before and after six weeks of treatment with AGO. In order to assess the treatment success, means of HAM-D17 and CDSS scores at both baseline and week 6 will be compared within the efficacy sample (at least one application of AGO, LOCF). The primary endpoint will be tested with a two-sided student's t-test at a level of statistical significance of ≤.05.
次要结局
- Secondary efficacy measures: Response rates(6 weeks and 3 months)
- Secondary tolerability and safety measures: General tolerability(6 weeks and 3 months)
- Secondary efficacy measures: Long-term efficacy(6 weeks and 3 months)
- Secondary efficacy measures: Psychosocial functioning(6 weeks and 3 months)
- Secondary tolerability and safety measures: Psychotic symptoms(6 weeks and 3 months)
- Secondary tolerability and safety measures: Pharmacokinetic interactions between AGO and antipsychotic agents(6 weeks and 3 months)
- Secondary efficacy measures: Remission rates(6 weeks and 3 months)
- Secondary efficacy measures: Cognitive functioning(3 months)