Fluoxetine Versus Fluoxetine Plus DU125530 in Latency of Antidepressant Response Shortening in Major Depressive Disorder
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Scores on Hamilton Depression Rating Scale
研究概览
简要总结
The purpose of this study is to examine whether the speed of the clinical antidepressant action of fluoxetine can be accelerated by administering DU125530 a full 5-HT1A antagonist.
详细描述
SSRI acts by blocking the serotonin transporter (5-HT), increasing the availability of serotonin at the synaptic cleft averting its reuptake. The increment of serotonin activates 5-HT1A presynaptic autoreceptors, resulting in a modulation in the release of serotonin by the presynaptic neuron. It is proposed that 5-HT1A receptor antagonism could accelerate the clinical effect of antidepressants by preventing this negative feedback.Preclinical data obtained with selective 5-HT1A antagonists, such as pindolol, and with mice lacking 5-HT1a receptors supports this hypothesis. Results on partial antagonists (pindolol) are conclusive in accelerating SSRI. It is reasonable to call into question whether a total antagonism of 5-HT1a receptors could imply a more rapid antidepressant response. To test this hypothesis we conducted a double blind, randomised, controlled trial with DU 123550 added to fluoxetine 20 mg/day
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
- •Consecutive eligible patients aged 18 to 70
- •Diagnosis of unipolar major depression using DSM-IV criteria with moderate to severe symptoms (score e 18 on the Hamilton Depression Rating Scale-HDRS- of 17 items).
- •There was a wash-out of 1 week of any antidepressant drug (specifically 28 days for fluoxetine) prior entering the study.
- •Written informed consent was obtained from all participants.
排除标准
- •Concurrent psychiatric disorders (DSM IV axis I, II cluster A or B)
- •Failure to respond to drug treatment in current depressive episode
- •Previous resistance to SSRIs or other antidepressant drug
- •Suicide risk score e 3 on the HDRS.
- •Participation in other drug trials within the previous month
- •Presence of delusions or hallucinations
- •History of substance abuse (including alcohol) in the past three months
- •Pregnancy or lactation
- •Organic brain disease or history of seizures
- •Serious organic illnesses such as hypo or hyperthyroidism,cardiac arrhythmias, asthma, diabetes mellitus.
- •Myocardial infarction in the past 6 month
- •Frequent or severe allergic reactions
- •Concomitant use of other psychotropic drugs (benzodiazepines were allowed), lockers or catecholamine-depleting agents
- •Current structured psychotherapy.
研究组 & 干预措施
Fluoxetine plus placebo
干预措施: Placebo (Drug)
Fluoxetine plus DU125530
干预措施: DU125530 (Drug)
结局指标
主要结局
Scores on Hamilton Depression Rating Scale
时间窗: 8 time points through 8 weeks
次要结局
未报告次要终点