Feasibility of Conducting a Clinical Trial Assessing Efficacy of Lactate as Adjunctive Therapy in Patients With Major Depressive Disorder

• Status: Not yet recruiting
• Trial end date: 2028-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire Vaudois
• Collaborator: Fondation de Préfargier

Criteria

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.