A Feasibility Single-center, Randomized, Double-blind, Placebo-controlled Study to Assess the Feasibility of Conducting a Full-scale Randomized Controlled Trial (RCT) Assessing Efficacy of Lactate as Adjunctive Therapy in Hospitalized Patients With Major Depressive Disorder
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 46
- 主要终点
- Feasibility as assessed by the recruitment rate
研究概览
简要总结
The goal of this clinical trial is to test the efficacy of lactate (a natural substance) in combination with standard antidepressant treatment, in patients hospitalized for a major depressive episode.
The main question[s] it aims to answer are:
- does lactate diminishes depression severity when administered in combination with antidepressant ?
- is it feasible to test lactate treatment in a large-scale clinical trial ? Participants will receive lactate intravenously daily (20 min infusion) for 5 days during hospitalisation (together with the standard antidepressant treatment).
Researchers will compare with a group receiving a placebo instead of lactate to see if lactate has antidepressant effects.
详细描述
In case of major depressive disorder (MDD), antidepressant medications are prescribed as standard treatment. The commonly used antidepressants have a delayed onset of therapeutic actions, many side effects and limited efficacy. In this regard, about 30-50% of MDD patients are unresponsive to any currently approved pharmacological treatment, emphasizing the need for novel types of drugs to treat major depression.
Several animal studies have shown that lactate, a substance naturally present in the body, has antidepressant effects.
The aim of this single-center study is to evaluate the feasibility of conducting a future large-scale clinical trial testing the efficacy of "sodium lactate" as an adjunctive treatment to a standardly prescribed antidepressant.
The study is recruiting patients hospitalized for a major depressive episode. Participants are assigned randomly to the "sodium lactate" group or the "placebo" group. The study treatment will be administered intravenously daily (2mmol/kg) for 5 days during hospitalization, in addition to standard antidepressant treatment. Patients will be followed during hospitalization and then on an outpatient basis at 6 and 12 weeks. The therapeutic effect of sodium lactate will be assessed with the MADRS score (depression severity scale) at 1, 2, 3, 6 and 12 weeks. Recruitment, adherence, retention, data completion and blinding maintenance rates will also be assessed to evaluate the feasibility. The effect on anxiety, perceived stress, insomnia, short-term depression remission rate, blood lactate level and length of hospitalization will also be evaluated.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Study consent signed
- •18 ≤ age ≤ 65 years old
- •Fluent in french
- •Recently (no more than 1 week) hospitalized for a primary diagnosis of MDD
- •Current major depressive episode as defined by DSM-5
- •Current MADRS score ≥18
- •Total number of MDD acute episodes ≤ 3
- •Total number of psychiatric medications ≤ 3 at admission
- •Total number of any medication ≤ 4 at admission
- •No signs or evidence indicating difficult intravenous access
- •Willing to hold a peripheral blood catheter for 5 days
排除标准
- •Bipolar depression
- •History of panic attacks
- •Severe substance use disorders according to DSM-5-TR criteria
- •Conditions predisposing to hypernatremia such as:
- •adrenocortical insufficiency,
- •diabetes type 1 and insulin-dependent type 2
- •extensive tissue injury
- •Known severe renal insufficiency
- •Known hepatic insufficiency (impaired lactate metabolism)
- •Known history of heart failure
- •Known history of Chronnic Obstructive Pulmonary Disease or respiratory failure
- •Known hypersentitivity to lactate
- •Hypernatremia with Na+ > 150 mmol/L (confirmed on 2 blood withdrawals)
- •Blood osmolality > 320 mmol/kg H2O
- •Hyperlactatemia > 2 mmol/l
- •Pregnant or lactating
- •Forbiden medications : Lithium
- •Participation to other clinical trials
- •Any medical conditions that could jeopardize patient's health in case of study participation according to the investigator
- •Inability to give informed consent (without capacity for discernment) as evaluated by the psychiatrist investigator or by by a delegated physician.
研究组 & 干预措施
Lactate
干预措施: Sodium lactate (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Feasibility as assessed by the recruitment rate
时间窗: 12 weeks
% of patients eligible among the informed patients
Feasibility as assessed by the blinding maintenance rate
时间窗: 12 weeks
% of patients with sustained blinding at week 1, 2, 3, 6 and 12
Feasibility as assessed by the adherence rate
时间窗: 12 weeks
% of patients completing the study intervention period among randomized patients
Feasibility as assessed by the retention rate
时间窗: 12 weeks
% of drop-outs among randomized patients at 3 weeks, 6 weeks and 12 weeks
Feasibility as assessed by the data completion rate of the therapeutic effect measures
时间窗: 12 weeks
% of patients with completed Montgomery Asberg Depression Rating Scale (MADRS) questionnaire at 1, 2, 3, 6 and 12 weeks among randomized patients
Feasibility as assessed by estimates of the therapeutic effect size on Montgomery Asberg Depression Rating Scale (MADRS) score
时间窗: 12 weeks
Estimate of mean difference on the change in MADRS score from baseline to week 1, 2, 3, 6 and 12 between patients randomized in lactate arm and in placebo arm, as well as their associated standard deviation.
次要结局
- Insomnia(12 weeks)
- Anxiety(12 weeks)
- Perceived stress(12 weeks)
- Short term depression remission rate(12 weeks)
- Hospitalization duration(12 weeks)
研究者
Sylfa Fassassi
Principal Investigator
Centre Hospitalier Universitaire Vaudois