Feasibility of Conducting a Clinical Trial Assessing Efficacy of Lactate as Adjunctive Therapy in Patients With Major Depressive Disorder
NCT ID: NCT06168175
Last Updated: 2023-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
46 participants
INTERVENTIONAL
2024-01-31
2028-01-31
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Lactate
Sodium lactate
2 mmol/kg, intravenous, daily for 5 consecutive days
Placebo
Placebo
intravenous, daily for 5 consecutive days
Interventions
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Sodium lactate
2 mmol/kg, intravenous, daily for 5 consecutive days
Placebo
intravenous, daily for 5 consecutive days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Fondation de Préfargier
UNKNOWN
Centre Hospitalier Universitaire Vaudois
OTHER
Responsible Party
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Sylfa Fassassi
Principal Investigator
Principal Investigators
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Pierre Marquet, MD
Role: STUDY_CHAIR
Centre Hospitalier Universitaire Vaudois
Central Contacts
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Other Identifiers
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2023-01702
Identifier Type: OTHER
Identifier Source: secondary_id
Lac-MDD
Identifier Type: -
Identifier Source: org_study_id