A Randomised, Parallel Group, Double Blind, Placebo Controlled, Add on Clinical Trial to Investigate Whether the Lithium Mimetic, Ebselen, Can Reduce Symptoms of Hypomania and Mania in Bipolar Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Young Mania Rating Scale (YMRS)
研究概览
简要总结
This study evaluates the effect of a 'lithium like' drug called ebselen (SP-1005) versus placebo as an 'add on' treatment to help stabilise hypo/manic symptoms in bipolar disorder. Half of the participants will receive ebselen and the other half placebo. The trial, will last a total of four weeks.
详细描述
Ebselen, a new drug for mania
Bipolar disorder, formerly known as manic depression, is a condition that affects mood, which can swing from one extreme to another.
Typically, there will be periods of:
- Depression - very low mood and energy levels
- Mania or hypomania (less severe) - very high mood and overactive energy levels
A drug called lithium, used to stabilise mood, is an important treatment for bipolar disorder but has a number of problematic side effects, is not well tolerated by patients and requires careful monitoring. To replace lithium with other, safer medicines would have clear advantages. The investigators are interested in an antioxidant medicine(substance that may prevent or delay cell damage) called ebselen which has been shown to work in a similar way as lithium and the investigators are investigating whether it might help improve recovery from manic episodes.
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
- •Participant is willing and able to give informed consent for participation in the trial.
- •Male or Female, aged 18-70 years
- •Diagnosed with bipolar disorder, screened using the Structured Clinical Interview for DSM-5 (SCID) to meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for Manic or Hypomanic Episode.
- •Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the trial
- •In the Investigator's opinion, is able and willing to comply with all trial requirements.
- •Willing to allow clinical care team (including General Practitioner (GP)) to be made aware of trial participation.
- •The Clinical team treating the patient are in agreement.
排除标准
- •Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
- •Known significant renal or hepatic impairment.
- •Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
- •Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
- •Participants who have participated in another research trial involving an investigational product in the past 12 weeks.
- •Clinically significant illicit substance or alcohol misuse where dependence criteria are satisfied.
- •Taking lithium.
- •Previous randomisation to this trial.
研究组 & 干预措施
Ebselen
Three Ebselen capsules each containing 200mg taken orally twice a day for 3 weeks
干预措施: Ebselen (Drug)
Placebo
Three Placebo capsules each containing 200mg taken orally twice a day for 3 weeks
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Change in Young Mania Rating Scale (YMRS)
时间窗: Change between groups, every week, up to 4 weeks
Difference in the 11 item clinician-rated YMRS between groups.Total score 0-60.
次要结局
- Change in Clinical Global Impressions Bipolar (CGI-BP) mania scale(Change between groups, every week, up to 4 weeks)
- Change in Quick Inventory of Depressive Symptomology-Self Rating 16 (QIDS-SR-16)(Change between groups, 3 x weekly, up to 4 weeks)
- Ebselen levels in Plasma sample(Once at week 1 visit)
- Change in Concomitant medication recorded(Change between groups, every week, up to 4 weeks)
- Change in Hamilton Rating Scale for Depression (HAM-D)(Change between groups, every week, up to 4 weeks)
- Compliance assessment(Change between groups, every week, up to 3 weeks)
- Change in Altman Self Rating Mania Scale (ASRM)(Change between groups, 3 x weekly, up to 4 weeks)
- Change in Actigraphy(Change in activity between groups, each 24 hours, up to 4 weeks)
- Change in Leeds Sleep Evaluation Questionnaire (LSEQ)(Change between groups, every week, up to 4 weeks)
- Levels of markers of inflammation in Plasma sample(Once at week 1 visit)
- Adverse Events reported(Every week, up to 4 weeks)