Feasibility of Conducting a Clinical Trial Assessing Efficacy of Lactate as Adjunctive Therapy in… (NCT06168175) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Feasibility of Conducting a Clinical Trial Assessing Efficacy of Lactate as Adjunctive Therapy in Patients With Major Depressive Disorder
46 participantsStarted 2024-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility as assessed by the recruitment rate
Timeframe: 12 weeks
2
Feasibility as assessed by the adherence rate
Timeframe: 12 weeks
3
Feasibility as assessed by the retention rate
Timeframe: 12 weeks
4
Feasibility as assessed by the data completion rate of the therapeutic effect measures
Timeframe: 12 weeks
5
Feasibility as assessed by estimates of the therapeutic effect size on Montgomery Asberg Depression Rating Scale (MADRS) score
Timeframe: 12 weeks
6
Feasibility as assessed by the blinding maintenance rate