NCT06168175Not yet recruitingPhase 2
Feasibility of Conducting a Clinical Trial Assessing Efficacy of Lactate as Adjunctive Therapy in Patients With Major Depressive Disorder
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
Source: ClinicalTrials.gov · Last updated 13 Dec 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 46 (estimated)
- First submitted
- 10 Nov 2023
- Start date
- Jan 2024
- Primary completion date
- Jan 2028
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Diseases
- Depression
- NCT number
- NCT06168175
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 46
- From Jan 2024 to the primary completion date, Jan 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Forbiden medications : Lithium
Other illness
- 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
- Any medical conditions that could jeopardize patient's health in case of study participation according to the investigator
Lab values
- Hypernatremia with Na+ \> 150 mmol/L (confirmed on 2 blood withdrawals)
- Hyperlactatemia \> 2 mmol/l
Other
- Bipolar depression
- Known hypersentitivity to lactate
- Blood osmolality \> 320 mmol/kg H2O
- Pregnant or lactating
- Participation to other clinical trials
- Inability to give informed consent (without capacity for discernment) as evaluated by the psychiatrist investigator or by by a delegated physician.
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.