Status:
NOT_YET_RECRUITING
Feasibility of Conducting a Clinical Trial Assessing Efficacy of Lactate as Adjunctive Therapy in Patients With Major Depressive Disorder
Lead Sponsor:
Centre Hospitalier Universitaire Vaudois
Collaborating Sponsors:
Fondation de Préfargier
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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....
Detailed Description
In case of major depressive disorder (MDD), antidepressant medications are prescribed as standard treatment. The commonly used antidepressants have a delayed onset of therapeutic actions, many side ef...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT06168175
Start Date
January 1 2024
End Date
January 1 2028
Last Update
December 13 2023
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.