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

NCT06168175 | Not Yet Recruiting Phase 2

• 2 other identifiers: Lac-MDD2023-01702
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief 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

Major Depressive Disorder

Keywords

Sodium lactate; Depression; Antidepressant; Lactate

Outcome Measures

Primary Outcomes (6)

• Feasibility as assessed by the recruitment rate

  % of patients eligible among the informed patients

  12 weeks

• Feasibility as assessed by the adherence rate

  % of patients completing the study intervention period among randomized patients

  12 weeks

• Feasibility as assessed by the retention rate

  % of drop-outs among randomized patients at 3 weeks, 6 weeks and 12 weeks

  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

  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.

  12 weeks

• Feasibility as assessed by the blinding maintenance rate

  % of patients with sustained blinding at week 1, 2, 3, 6 and 12

  12 weeks

Secondary Outcomes (5)

• Anxiety

  12 weeks

• Perceived stress

  12 weeks

• Insomnia

  12 weeks

• Short term depression remission rate

  12 weeks

• Hospitalization duration

  12 weeks

Study Arms (2)

Lactate

EXPERIMENTAL

Drug: Sodium lactate

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Sodium lactate DRUG

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

Lactate

Placebo DRUG

intravenous, daily for 5 consecutive days

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Study consent signed
• ≤ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead
• Fondation de Préfargier: collaborator

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Sodium Lactate

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Lactates; Hydroxy Acids; Carboxylic Acids; Organic Chemicals

Study Officials

• Pierre Marquet, MD

  Centre Hospitalier Universitaire Vaudois

  STUDY CHAIR

Central Study Contacts

Sylfa Fassassi,, MD

CONTACT

+41 21 314 31 11; sylfa.fassassi@chuv.ch

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: December 13, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: December 13, 2023

Record last verified: 2023-12