Add-on Buprenorphine at Analgesic Doses for the Treatment of Severe Suicidal Ideas During a Major Depressive Episode
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 9
- 主要终点
- Changes in Beck Scale for Suicidal Ideation (SSI) scores from Day 0 to 7
研究概览
简要总结
This study aims at investigating if adjunctive buprenorphine at low dose to treatment as usual is effective in reducing severe suicidal ideas in major depressive episode, and at determining the most effective dose.
详细描述
Participants will be randomized to two doses of buprenorphine (0.4mg and 0.8mg) or placebo. The duration of treatment will be 21 days with 7 days withdrawal period. Two follow-up phone calls at 3 and 6 months will investigate occurence of suicidal behavior.
The main outcome will be changes in suicidal ideas levels during the first week.
Secondary outcomes will be changes in suicidal ideas during the following 21 days, changes in depression and psychological pain levels over the first 28 days, dropout rates, reasons and occurence of side effects over the first 28 days, withdrawal symptoms dung the withdrawal period, changes in neuropsychological and neuroimaging measures between Day 0 and Day 28.
Blood and stool samples will be collected at 4 time points and stored in a biobank for future analyses.
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
- Double (Participant, Investigator)
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
- •The patient has been correctly informed.
- •The patient must have given his/her informed and signed the consent form.
- •The patient must be insured or beneficiary of a health insurance plan.
- •The patient is at least 18 years old and 65 years old at the most.
- •The patient is hospitalized or followed in consultation.
- •The patient has a current major depressive episode without psychotic features according to the criteria of the "Diagnostic and Statistical Manual of Mental Disorders"
- •The patient has a score > 20 of the "Montgomery-Asberg Depression Rating Scale".
- •The patient has a current Scale for Suicidal Ideation (SSI) score > 8.
排除标准
- •The patient is participating in another interventional trial;
- •The patient is in an exclusion period determined by a previous study;
- •The patient is under judicial protection, or is an adult under guardianship;
- •The patient is under compulsory admission;
- •The patient refuses to sign the consent;
- •it is impossible to correctly inform the patient.
- •The patient is pregnant or breastfeeding.
- •The patient suffers from schizophrenia;
- •The patient suffered from moderate to severe alcohol use disorder or substance use disorder (except tobacco and caffeine) over the last 12 months according to DSM-5 criteria ;
- •The patient currently suffers from severe and/or unstable medical condition (including severe respiratory or hepatic insufficiency) or a painful medical condition;
- •The patient has a current known sleep apnea.
- •The patient currently takes analgesic treatment (including Nonsteroidal anti-inflammatory drug and paracetamol);
- •The patient currently takes central nervous depressant drugs at sedative doses (based on the investigator's assessment), including benzodiazepines, antihistamines, and sedative antipsychotics;
- •The patient currently takes major CYP3A4 Inhibitors and inducers;
- •The patient currently takes has received Electroconvulsivotherapy over the last 3 months.
研究组 & 干预措施
Placebo
2 placebo pills sublingual during 28 days
干预措施: Placebo (Drug)
0.4mg buprenorphine
1 pill of 0.4 mg buprenorphine + 1 placebo pill per day for 21 days, then 2 placebo pills per day for 1 week, all sublingual.
干预措施: Buprenorphine (Drug)
0.8mg buprenorphine
1 pill of 0.4 mg buprenorphine + 1 placebo pill per day for 3 days, then 2 pills of 0.4mg buprenorphine per day for 18 days, then 1 pill of 0.4 mg + 1 placebo pill per day for 3 days, then 2 placebo pills per day for 4 days, all sublingual.
干预措施: Buprenorphine (Drug)
结局指标
主要结局
Changes in Beck Scale for Suicidal Ideation (SSI) scores from Day 0 to 7
时间窗: 7 days
Clinician-based questionnaire measuring level of suicidal ideas over the last 7 days; 21 items scored 0 to 2; total score ranges from 0 to 38 (last 2 items not counted), higher scores mean more intense suicidal ideas.
次要结局
- Changes in Beck Scale for Suicidal Ideation (SSI) scores(Day 8 to day 28)
- Changes in Beck Depression Inventory II (BDI-II) scores from Day 0 to 28(28 days)
- Changes in Montgomery-Asberg Depression Rating Scale (MADRS) from Day 0 to 28(28 days)
- Changes in Physical and Psychological Pain - Visual Analog Scale (PPP-VAS) scores from Day 0 to 28(28 days)
- Reasons for discontinuing treatment over the first 28 days(28 days)
- Side effects over the first 28 days(28 days)
- Withdrawal symptoms(Day 22 to day 28)
- Occurence of a suicide attempt during the whole study(180 days)
- Changes in Iowa Gambling Task (IGT) scores between Day 0 and 28(28 days)
- Changes in N-Back test scores between Day 0 and 28(28 days)
- Changes in Go/No-Go test between Day 0 and 28(28 days)
- Changes in Trail Making Test (TMT) scores between Day 0 and 28(28 days)
- Changes in Magnetic Resonance Imaging (MRI) Resting State (RS) measures between Day 0 and 28(28 days)
- Changes in Implicit Association Test (IAT) scores between Day 0 and 28(28 days)
- Changes in Magnetic Resonance Imaging (MRI) Diffusion Tensor Imaging (DTI) measures between Day 0 and 28(28 days)
- Changes in modified Stroop test scores between Day 0 and 28(28 days)
- Changes in verbal fluency test scores between Day 0 and 28(28 days)
- Changes in Magnetic Resonance Imaging (MRI) T1 measures between Day 0 and 28(28 days)
- Changes in Magnetic Resonance Imaging (MRI) T2 measures between Day 0 and 28(28 days)