2023-508125-27-00招募中2 期
Esketamine nasal spray (Spravato) for the treatment of therapy-resistant bipolar depression. An open-label pilot trial.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Efficacy as determined by response and remission rates: response is defined as a 50% or more reduction of the MADRS score. Remission is defined as a MADRS score that falls under ten.
研究概览
简要总结
The study is an open-label pilot study of esketamine nasal spray in patients with treatment-resistant bipolar depression to assess efficacy in global, but most importantly safety and tolerability. At the current stage of drug trials involving re-designation of esketamine nasal spray, this study design is the most appropriate as this may form the base towards a future randomized, placebo-controlled trial.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of bipolar I or II disorder
- •Age between 18 and 75
- •MADRS scores above 18
- •Current episode of depression
- •Meeting the criteria of a current treatment resistant depression defined as a failure to respond to at least two different antidepressant or mood stabilizing agents during a sufficient amount of time at a sufficient dosage
- •Currently be on treatment with a mood stabilizer, but may not have been treated with more than five anti-depressant therapies for the current episode
- •Medication at a stable dosage for at least two weeks
- •Availability on Monday and Friday
排除标准
- •Known allergies against esketamine, or it's excipients
- •Using ketamine in a recreative manner at present, or with recreative use in the past 6 months
- •Women who are breastfeeding
- •Previously been treated with esketamine or have been part of an esketamine trial
- •Unable to follow instructions or unable to make their own decisions regarding treatment
- •Known cardiovascular problems that could result in severe side effects due to a rise of blood pressure, for example: intracranial, abdominal or thoracic aneurysms and patients with recent cardiovascular events (less than six weeks ago), such as a myocardial infarction
- •Pregnancy as measured with a blood test at baseline
- •Suicidal to a point where closed admission is needed or the C-SSRS is four or higher
- •Psychosis (psychotic depression) as assessed with the MINI
- •Ketamine use disorder in their lifetime as assessed with the MINI
- •An active alcohol- or drug use disorder as assessed with the MINI
结局指标
主要结局
Efficacy as determined by response and remission rates: response is defined as a 50% or more reduction of the MADRS score. Remission is defined as a MADRS score that falls under ten.
Efficacy as determined by response and remission rates: response is defined as a 50% or more reduction of the MADRS score. Remission is defined as a MADRS score that falls under ten.
次要结局
- Tolarability will be determined by dropout rates during the whole study.
- Safety will be determined by the number of side effects. The potential effect of conversion to mania will be measured by a YMRS of 20 or more points, indicating at least a mild mania. All other psychiatric side effects, such as psychosis and suicidality as well as somatic side effects will be meticulously monitored.
- Relapse will be monitored and measured by: admission to a psychiatric hospital or ward due to depressive symptoms; a suicide attempt or admission to prevent suicide; an increase in depressive symptoms measured by the MADRS of >25% or above 22 points after initial response or remission following treatment.
研究者
Dr. Max de Leeuw
Scientific
Academisch Ziekenhuis Leiden
研究点 (1)
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