Major Depressive DisorderPhase 2NCT06168175
Feasibility of Conducting a Clinical Trial Assessing Efficacy of Lactate as Adjunctive Therapy in Patients With Major Depressive Disorder
A Phase 2 study testing Sodium lactate in people with Major Depressive Disorder, run by Centre Hospitalier Universitaire Vaudois.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Sodium lactate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Jan 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Major Depressive Disorder
- Being tested
- Sodium lactate, Placebo
- Keywords
- Sodium lactate, Depression, Antidepressant, Lactate
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium lactateDrug
2 mmol/kg, intravenous, daily for 5 consecutive days
PlaceboDrug
intravenous, daily for 5 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Lactate | Experimental | Not described Receives: Drug: Sodium lactate |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as assessed by the recruitment rate
% of patients eligible among the informed patients
Measured: 12 weeks
Feasibility as assessed by the adherence rate
% of patients completing the study intervention period among randomized patients
Measured: 12 weeks
Feasibility as assessed by the retention rate
% of drop-outs among randomized patients at 3 weeks, 6 weeks and 12 weeks
Measured: 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
Measured: 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.
Measured: 12 weeks
Feasibility as assessed by the blinding maintenance rate
% of patients with sustained blinding at week 1, 2, 3, 6 and 12
Measured: 12 weeks
Secondary outcomes (5)
Anxiety
Generalized Anxiety Disorder - 7 items (GAD-7 score) ; minimum and maximum values : 0 - 21 ; Lower scores mean a better outcome
Measured: 12 weeks
Perceived stress
Perceived Stress Scale (PSS score) ; minimum and maximum values : 0 - 40 ; Lower scores mean a better outcome
Measured: 12 weeks
Insomnia
Insomnia Severity Index (ISI score) ; minimum and maximum values : 0 - 28 ; Lower scores mean a better outcome
Measured: 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
Measured: 12 weeks
Hospitalization duration
Number of days of hospitalization
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study startJan 2024 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation de Préfargier
- Responsible party
- Principal investigator, Sylfa Fassassi, Centre Hospitalier Universitaire Vaudois
- Investigators
- Pierre Marquet, MD, Study chair, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06168175
- Sponsor's protocol ID
- Lac-MDD
- Other IDs
- 2023-01702, 2023
- Status last verified
- Dec 2023
- First submitted
- 10 Nov 2023
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06168175
- Acronym / sponsor ID
- Lac-MDD
- Conditions
- Major Depressive Disorder
- Keywords
- Sodium lactate, Depression, Antidepressant, Lactate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Collaborators
- Fondation de Préfargier
- Study start
- Jan 2024 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 13 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactate | Experimental | Drug: Sodium lactate |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (20 listed)
- Bipolar depression
- History of panic attacks
- Severe substance use disorders according to DSM-5-TR criteria
- Conditions predisposing to hypernatremia such as:
- Known severe renal insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium lactate2 mmol/kg, intravenous, daily for 5 consecutive days | Drug | Lactate |
| Placebointravenous, daily for 5 consecutive days | Drug | Placebo |
Primary outcome
Feasibility as assessed by the recruitment rate
Time frame: 12 weeks
% of patients eligible among the informed patients
Feasibility as assessed by the adherence rate
Time frame: 12 weeks
% of patients completing the study intervention period among randomized patients
Feasibility as assessed by the retention rate
Time frame: 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
Time frame: 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
Time frame: 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.
Feasibility as assessed by the blinding maintenance rate
Time frame: 12 weeks
% of patients with sustained blinding at week 1, 2, 3, 6 and 12
5 secondary outcomes
Anxiety
Time frame: 12 weeks
Perceived stress
Time frame: 12 weeks
Insomnia
Time frame: 12 weeks
Short term depression remission rate
Time frame: 12 weeks
Hospitalization duration
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pierre Marquet, MD study chair
Centre Hospitalier Universitaire Vaudois
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sodium lactate in people with Major Depressive Disorder, run by Centre Hospitalier Universitaire Vaudois.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sylfa Fassassi,, MD (+41 21 314 31 11, sylfa.fassassi@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as assessed by the recruitment rate (time frame: 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023.