Monocentric, randomized, double-blind, placebo-controlled study to assess the feasibility of conducting a large-scale clinical trial evaluating the efficacy of lactate as an adjunct treatment in hospitalized patients suffering from a major depressive episode.
Résumé de l'étude
In cases of major depressive disorder, antidepressants are prescribed as standard. The therapeutic effects of commonly used antidepressants often take a long time to set in, and the side effects are numerous. Additionally, about 30 to 50% of patients with major depressive disorder do not respond to treatment. Several animal studies have shown that lactate, a substance naturally present in the body, has antidepressant effects. The aim of this monocentric study is to evaluate the feasibility of conducting a future large-scale clinical trial testing the efficacy of "sodium lactate" as an adjunct treatment to a standard prescribed antidepressant. The study is aimed at patients hospitalized for a major depressive episode. Participants are randomly and blindly assigned to the "sodium lactate" group or the "placebo" group. The study treatment will be administered intravenously once a day for 5 days during hospitalization, in addition to the standard antidepressant treatment. Patients will be followed during hospitalization and then outpatient at 6 and 12 weeks. Feasibility will be assessed by measuring the therapeutic effect of sodium lactate via the MADRS score (depression scale) at 1, 2, 3, 6, and 12 weeks, as well as by the recruitment, adherence, retention rates, completeness of data, and maintenance of blinding. The effect on anxiety, stress, insomnia, short-term remission rate, and blood lactate level will also be evaluated.
(BASEC)
Intervention étudiée
Sodium lactate
(BASEC)
Maladie en cours d'investigation
Major depressive episode.
(BASEC)
• Informed consent signature • 18 ≤ age ≤ 65 years • Fluent in French • Recently (not more than one week) hospitalized for a primary diagnosis of major depressive episode • Current major depressive episode as defined by DSM-5 • Current MADRS score ≥18 • Total number of acute episodes of major depressive disorder ≤ 4 • Total number of psychiatric medications ≤ 4 at admission • Total number of medications ≤ 5 at admission • No signs or evidence indicating difficult intravenous access • Willing to wear a peripheral venous catheter for 5 days (BASEC)
Critères d'exclusion
• Bipolar disorder • History of panic attacks • Severe substance use disorders according to DSM-5-TR criteria • Conditions predisposing to hypernatremia such as: adrenal insufficiency, type 1 diabetes and insulin-dependent type 2 diabetes, extensive tissue injury • Known severe renal insufficiency • Known liver insufficiency (alteration of lactate metabolism) • Known history of heart disease • Known history of chronic obstructive pulmonary disease or respiratory failure • Known hypersensitivity to lactate • Hypernatremia with Na+ > 150 mmol/L (confirmed by 2 blood tests) • Blood osmolality > 320 mmol/kg H2O • Hyperlactatemia > 2 mmol/l • Pregnancy or breastfeeding • Treatment with Lithium • Participation in other clinical trials • Any medical condition that may jeopardize the patient's health in case of participation in the study according to the investigator • Inability to give informed consent (lack of discernment) (BASEC)
Lieu de l’étude
Lausanne
(BASEC)
Sponsor
Centre Hospitalier Universitaire Vaudois
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Dr Sylfa Fassassi
+41 21 314 34 55
sylfa.fassassi@clutterchuv.chCentre Hospitalier Universitaire Vaudois
(BASEC)
Informations générales
Centre Hospitalier Universitaire Vaudois
(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique du Vaud
(BASEC)
Date d'approbation du comité d'éthique
13.11.2023
(BASEC)
Identifiant de l'essai ICTRP
NCT06168175 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
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. (BASEC)
Titre académique
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 (ICTRP)
Titre public
Feasibility of Conducting a Clinical Trial Assessing Efficacy of Lactate as Adjunctive Therapy in Patients With Major Depressive Disorder (ICTRP)
Maladie en cours d'investigation
Major Depressive Disorder
(ICTRP)
Intervention étudiée
Drug: Sodium lactate
Drug: Placebo
(ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Critères d'inclusion/exclusion
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 evaluated by
the psychiatrist investigator or by by a delegated physician.
(ICTRP)
non disponible
Critères d'évaluation principaux et secondaires
Feasibility as assessed by estimates of the therapeutic effect size on Montgomery Asberg Depression Rating Scale (MADRS) score
Feasibility as assessed by the blinding maintenance rate
Feasibility as assessed by the adherence rate
Feasibility as assessed by the recruitment rate
Feasibility as assessed by the retention rate
Feasibility as assessed by the data completion rate of the therapeutic effect measures
(ICTRP)
Hospitalization duration
Insomnia
Short term depression remission rate
Anxiety
Perceived stress
(ICTRP)
Date d'enregistrement
10.11.2023 (ICTRP)
Inclusion du premier participant
01.01.2024 (ICTRP)
Sponsors secondaires
Fondation de Préfargier
(ICTRP)
Contacts supplémentaires
Pierre Marquet, MD, Centre Hospitalier Universitaire Vaudois (ICTRP)
ID secondaires
Lac-MDD, 2023-01702 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT06168175 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible