A Phase 2 interventional study of Sodium lactate and Placebo in Major Depressive Disorder, sponsored by Centre Hospitalier Universitaire Vaudois. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-12-13.
Sponsored by Centre Hospitalier Universitaire Vaudois · Phase 2, Interventional, and Treatment
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:
Researchers will compare with a group receiving a placebo instead of lactate to see if lactate has antidepressant effects.
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.
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's planned enrollment of 46 is below the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →Centre Hospitalier Universitaire Vaudois is the lead sponsor of 203 studies on the registry; 47 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Conditions predisposing to hypernatremia such as:
Drug: Sodium lactate
Drug: Placebo
2 mmol/kg, intravenous, daily for 5 consecutive days
intravenous, daily for 5 consecutive days
Feasibility as assessed by the recruitment rate
% of patients eligible among the informed patients
Time frame: 12 weeks
Feasibility as assessed by the adherence rate
% of patients completing the study intervention period among randomized patients
Time frame: 12 weeks
Feasibility as assessed by the retention rate
% of drop-outs among randomized patients at 3 weeks, 6 weeks and 12 weeks
Time frame: 12 weeks
Feasibility as assessed by the data completion rate of the therapeutic effect measures
% of patients with completed Montgomery Asberg Depression Rating Scale (MADRS) questionnaire at 1, 2, 3, 6 and 12 weeks among randomized patients
Time frame: 12 weeks
Feasibility as assessed by estimates of the therapeutic effect size on Montgomery Asberg Depression Rating Scale (MADRS) score
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.
Time frame: 12 weeks
Feasibility as assessed by the blinding maintenance rate
% of patients with sustained blinding at week 1, 2, 3, 6 and 12
Time frame: 12 weeks
Anxiety
Generalized Anxiety Disorder - 7 items (GAD-7 score) ; minimum and maximum values : 0 - 21 ; Lower scores mean a better outcome
Time frame: 12 weeks
Perceived stress
Perceived Stress Scale (PSS score) ; minimum and maximum values : 0 - 40 ; Lower scores mean a better outcome
Time frame: 12 weeks
Insomnia
Insomnia Severity Index (ISI score) ; minimum and maximum values : 0 - 28 ; Lower scores mean a better outcome
Time frame: 12 weeks
Short term depression remission rate
Montgomery Asberg Depression Rating Scale (MADRS score \< 7) ; minimum and maximum values : 0 - 60 ; Lower scores mean a better outcome
Time frame: 12 weeks
Hospitalization duration
Number of days of hospitalization
Time frame: 12 weeks
No study locations are listed for this record.
This study is not yet recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire Vaudois