Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression: a Pragmatic Head-to-head Open, Randomized Multicenter Study: The 9th Study of the Danish University Antidepressant Group (DUAG 9)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Change in Hamilton Depressions scale, version 6 (HDS-6)
研究概览
简要总结
The goal is to study the effect of lithium compared to cariprazine in patients with depression in a bipolar disease.
The main question it aims to answer is:
Difference in change between the two groups from baseline to after 8 weeks treatment on Hamilton Ratings Scale for Depression, 6-item version (HDS-6)
Participants will be randomized to treatment with either lithium or cariprazin.
- Will meet for interview and ratings 4 times during study period.
- In two meetings, there will be made blood samples and ECG. At one meeting also a Urine sample.
- Will be contacted for telephone interviews at 6 occasions.
详细描述
The primary aim is to investigate whether cariprazine is superior to lithium or vice versa in the acute treatment of patients with bipolar type 1 or 2 in a current depressive episode measured as change on the Hamilton Depression Scale, 6 item version (HDS-6) from baseline to 8 weeks of treatment. Secondarily, we aimed at comparing the two study medications on various other clinically relevant variables.
These include depressive and manic symptomatology, sleep patterns, general well-being, cognitive function, social functioning and suicidal ideation.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of bipolar disorder, type 1 or type 2, and a current episode of depression according to DSM-5
- •Severity of depression: A score of at least 21 on the self-reported Major Depression Inventory (MDI).
- •No start or dose increase of psychotropic medication (except for benzodiazepines and benzodiazepine-like drugs (zopiclone, zolpidem, and melatonin)) in the two weeks prior to inclusion.
- •No new start of formalized psychotherapy sessions, excluding psychoeducation, during the 4 weeks prior to inclusion.
- •Age criteria: Subjects must be at least 18 years old and below 65 at the time of randomization.
- •The duration of the current depressive episode must be between 4 and 52 weeks as judged by the investigator at the time of randomization.
- •Clinical uncertainty regarding which of the alternatives, cariprazine and lithium, would be the better choice in the specific case.
- •Female participants should be sterile or non-fertile or, in case of being fertile, they must have a negative pregnancy test AND use safe anticonception.
- •Signed document of informed consent.
排除标准
- •Prior or ongoing acute treatment of a depressive episode lasting > 14 days with either lithium or cariprazine as judged by the investigator.
- •ECT within the current depressive episode.
- •A score of MAS >
- •A diagnosis of dementia.
- •High risk of non-adherence at the investigator's discretion.
- •Not understanding the Danish language as judged by the investigator
- •Psychiatric coercion in the form of forced admission or detainment OR sentence to forensic psychiatric care.
- •Presence of clinically relevant delusions, hallucinations or other psychotic symptoms as judged by the investigator.
- •Suicidality according to C-SSRS with a positive response to question 4 or 5 or upon investigator's discretion.
- •Medical conditions like cancer, kidney failure, epilepsy, deep brain stimulation device, or other medical conditions interfering with study the outcome and safety as judged by investigator's discretion.
- •Current harmful use or dependency of alcohol or drugs according to DSM-
- •Known allergy to any of the substances in the study medication.
研究组 & 干预措施
Lithium
Lithium citrate from 12 mmol increased to result in af 12-hour se-lithium between 0.6 and 0.8 mmol/l
干预措施: Lithium (Drug)
Cariprazine
Cariprazine from 1.5 mg to 3 mg daily in a single dose.
干预措施: Cariprazine (Drug)
结局指标
主要结局
Change in Hamilton Depressions scale, version 6 (HDS-6)
时间窗: 8 weeks
The primary aim is to investigate whether cariprazine is superior to lithium or vice versa in the acute treatment of patients with bipolar type 1 or 2 in a current depressive episode measured as change on the Hamilton Depression Scale, 6 item version, HDS-6. (Values 0- 22, higher scores mean a worse outcome).
次要结局
- Difference-in-difference for COBRA(Week 8)
- Difference-in-difference for MES(Week 4 and 8)
- Difference-in-differences for MADRS(Week 4 and 8)
- Difference-in-difference for HDS-17(Week 4 and 8)
- Difference-in-differences in HDS-6 for the PP 8 population(8 weeks)
- Between-groups difference in proportion of responders and remitters(Week 4 and 8)
- Between-groups difference in "(switch to mania or hypomania) / (response) -ratio",(up to 8 weeks)
- Between-group differences in reason for and time to all cause treatment discontinuation(up to 8 weeks)
- Between-group difference in treatment compliance.(up to 8 weeks)
- Between-group difference in reasons for premature discontinuation(up to 8 weeks)
- Difference-in-difference for MAS(Week 4 and 8)
- Between-groups difference in proportion of responders and remitters in HDS-6 Scores.(Week 4 and week 8)
- Between-groups difference in the proportion of patients with 'acceptable wellbeing'(up to 8 weeks)
- Between-groups difference in proportion of switches to mania/hypomania.(up to 8 weeks)
- Difference-in-difference for YMRS(Week 4 and 8)
- Difference-in-differences for ASRM-14(Week 4 and 8)
- Difference-in-differences for MDI(Week 4 and 8)
- Difference-in-differences for WHO-5 questionnaire(Week 4 and 8)
- Difference-in-difference for SCIP(Week 8)
- Difference-in-difference for FAST(Week 4 and 8)
- Difference-in-difference for PSQI(Week 4 and 8)
- Difference-in-difference for CGI-S(Week 4 and 8)
- Difference-in-difference for CGI-I(Week 4 and 8)
- Difference-in-difference for C-SSRS(Week 4 and 8)
- Difference-in-difference for accumulated benzodiazepine dose(Up to 8 weeks)
- Difference-in-difference for time to all-causes discontinuation(Up to 8 weeks)
- Difference-in-difference for time to all-causes. all-causes study endpoint.(Up to 8 weeks)
- Between-group difference in reasons for time to all cause discontinuation.(Up to 8 weeks)
- Between-group difference in reasons for treatment expectation.(Up to 8 weeks)
- Between-group difference in reasons for adverse events.(Up to 8 weeks)
- Between-group difference in reasons for serious adverse events.(Up to 8 weeks)
研究者
René Ernst Nielsen
MD, PhD, Professor
Aalborg University Hospital