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

NCT06168175 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2023-12-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Sodium lactate

2 mmol/kg, intravenous, daily for 5 consecutive days

DRUG

Placebo

intravenous, daily for 5 consecutive days

Sponsors & Collaborators

  • Fondation de Préfargier

    collaborator UNKNOWN

  • Centre Hospitalier Universitaire Vaudois

    lead OTHER

Principal Investigators

  • Pierre Marquet, MD · Centre Hospitalier Universitaire Vaudois

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-31
Primary Completion
2028-01-31
Completion
2028-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06168175 on ClinicalTrials.gov