A Randomized, Open-label, Trial of Lithium Versus Paroxetine in Subjects With Major Depression Who Have a Family History of Bipolar Disorder or Completed Suicide
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Montgomery Asberg Depression Rating Scale (MADRS)
研究概览
简要总结
This study is being done to look at how well people respond to two different drug treatments for depression. Clinically, people can respond differently to different treatments for reasons which are not always clear. Some research shows that people with a family history of bipolar disorder or completed suicide may react differently to standard medications used to treat depression than those without a family history. The investigators need to know if these drugs are effective to use in patients with depression who have a family history of bipolar disorder or completed suicide.
详细描述
Lithium is a mood stabilizing drug that has been used to treat people with both bipolar disorder and depression for the last 50 years. It is available to the public by prescription in Canada and has been used by millions of people world wide. Paroxetine is an antidepressant drug that has been used to treat people with depression for the past 10 years. It is also available to the public by prescription in Canada and has been used by millions world wide.
Subjects who join the study, will be given one of the study drugs, either lithium or paroxetine.
Subjects will be randomized "like the flip of a coin" to receive either lithium or paroxetine.
The study drug will be taken once a day by mouth and the daily dose adjusted to find the right dose for the subject. The study drug will be taken for a 6-week period and subjects will be assessed by the research team on a weekly basis.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •men or women
- •age of 18 years or older
- •meet criteria for major depressive episode, and have a family history of bipolar disorder or completed suicide
排除标准
- •subjects not able to give informed consent
- •pregnant or breast-feeding women
- •current panic disorder, post traumatic stress disorder or psychosis
- •subjects with a history of mania or hypomania
- •subjects with active substance abuse or dependence in the last 6 months
- •current depressive episode less than 4 weeks or greater than 12 months in duration
- •adequate trial of lithium or paroxetine (lithium level ≥ 0.6mmols/l; paroxetine 20mgs ≥ 5 weeks) for this episode of depression
- •concurrent use of other antidepressants or augmenting agents for the treatment of depression
- •clinically significant medical illness, in particular renal impairment
研究组 & 干预措施
Lithium
Following the enrollment period, subjects will enter a six-week randomized treatment period with either lithium or paroxetine. Lithium carbonate will be commenced at 600mgs hs, with increase to 900mgs at day 7. Dose will be flexibly titrated to give a serum level between 0.5 and 1.1mmol/l. At visit 4, the dose of lithium may be adjusted (within the range of 0.6 and 1.1 mmol/l).
干预措施: Lithium (Drug)
Paroxetine
Following the enrollment period, subjects will enter a six-week randomized treatment period with either lithium or Paroxetine.Paroxetine will be commenced at 10mgs and increased to 20mgs on day 7.At visit 4, the dose of paroxetine may be increased to 40mgs, if there is no response (less than 20% reduction in MADRS score) as per current Canadian guidelines.
干预措施: Paroxetine (Drug)
结局指标
主要结局
Montgomery Asberg Depression Rating Scale (MADRS)
时间窗: Assessed after 6 weeks of treatment
The primary outcome measure will be reduction in the score on the Montgomery Asberg Depression Rating Scale (MADRS), which has become the standard outcome tool in clinical trials for assessing symptoms of depression. Response will be defined as 50% reduction in MADRS Remission will be defined as MADRS ≤ 12.
次要结局
- The Young Mania Rating Scale (YMRS)(Assessed after 6 weeks of treatment)
- The Clinical Global Impression (CGI)(Assessed after 6 weeks of treatment)
- Treatment -emergent symptom checklist and questionnaire(Assessed over 6 weeks of treatment)
- The Columbia Suicide Classification Scale(Assessed over 6 weeks of treatment.)
- Barnes Akathisia Rating Scale (BARS)(Assessed over 6 weeks of treatment)
研究者
Claire O'Donovan
MB FRCPC
Nova Scotia Health Authority