Optimizing Response to Li Treatment Through Personalized Evaluation of Individuals With Bipolar I Disorder: The R-LiNK Initiative
试验速览
- 阶段
- 不适用
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Responder
研究概览
简要总结
Bipolar disorder (BD), especially BD type I, is a highly prevalent mental disorder and a is a highly prevalent mental disorder and an important factor for suicide. Lithium is the key treatment for prevention of BD relapse and has a proven suicide prevention effect. Whilst many cases become asymptomatic with lithium treatment, the majority show sub-optimal response.
The objectives of this project are to:
- improve outcomes of bipolar I disorder (BDI) cases prescribed lithium through the application of stratified approaches
- optimize the early prediction of lithium response using a set of multi-modal biomarkers ("blood omics", Magnetic Resonance Imaging and Li7-Magnetic Resonance Spectroscopy derived-markers)
- develop a multidisciplinary multinational network of experts to undertake this and future projects on personalized diagnostics and therapeutics and
- implement new, powerful technologies to characterize brain lithium distribution and the blood molecular signature of lithium in responders and non-responders.
This cutting edge approach will identify the eligibility criteria for treatment with lithium in BD in terms of response, safety and tolerability.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Decision to prescribe Li as a prophylactic treatment based on clinicians' assessment
- •Confirmed diagnosis of BD1 according to DSM-5 criteria
- •Aged 18-70 years.
- •Able and willing to give written informed consent
- •consents to blood sample for the purpose of the RLiNK study
- •Covered by a Social Security Insurance where applicable
- •Patients on Curatorship (consent form signed by the patient and specific consent form for the curator)
排除标准
- •Trial of Lithium undertaken within the last 6 months
- •Lifetime history of mood disorder better explained by a DSM-5 definition for schizoaffective disorder
- •Pre-lithium screening suggest that Lithium initiation is contraindicated:
- •Incompatible concurrent treatments: long-term use of non- steroidal anti-inflammatory drug or diuretics for a known and established comorbid disorder with no possible alternative treatment (i.e. absolute contra-indication to Li treatment)
- •Health issues (risk of worsening of a pre-existing condition) Psoriasis, Brugada syndrome
- •Renal dysfunction: Glomerular Filtration rate below 60mL/min/1.73m 2
- •On-going Pregnancy or planned pregnancy on the next 2 years
- •Lactating and breast feeding women (see SmPc)
- •Pregnant women
研究组 & 干预措施
bipolar I disorders who initiate lithium treatment
干预措施: lithium treatment (Drug)
结局指标
主要结局
Responder
时间窗: month 24
Good Responder The individual meets criteria for sustained remission, namely they experience euthymia (defined as a score on the Quick Inventory of Depressive Symptoms (qIDS)\<6 and the Bech Rafaelson Mania Scale (BRMS)\<7) for at least 8 weeks during the two-year follow-up period without evidence of relapse into a syndromal episode of BD at any time after achieving sustained euthymia. AND No addition of a new mood stabilizer with the purpose of promoting mood stabilisation after lithium initiation Non Responder The individual: Fails to meet criteria for sustained remission (euthymia defined as a score on the qIDS\<6 and the BRMS\<7 for a minimum period \>=8 consecutive weeks) during the two-year follow-up. OR Experiences \>=1 relapse into a syndromal episode of BD of any polarity during the two-year follow-up period without any period of sustained remission Definition of a Partial Responder All cases not fulfilling the criteria of Good Responders or Non Responders
次要结局
- Adherence(Month 24)
- Alda Scale(Month 24)
- Responder - sensitivity(Month 24)
- Time to new BD(Month 24)
- Time to BD hospitalization(Month 24)
- WHODAS(Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, month 24)
- Cost-effectiveness(Month 24)
- Monthly qIDS(monthly from month 1 to month 24)
- Time to new mood stabilizer(Month 24)
- Monthly BRMS(monthly from month 1 to month 24)
- Monthly BPRS(monthly from month 1 to month 24)
- Monthly ISS(monthly from month 1 to month 24)
- Monthly LIFE-II(monthly from month 1 to month 24)