Actively Recruiting
Early Effects of Ketamine vs Placebo With Venlafaxine in Severe Depression Patients
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-09-03
60
Participants Needed
4
Research Sites
75 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Unipolar major depressive disorder is the leading cause of disability worldwide. The most commonly used treatments for major depressive episodes (MDE) are antidepressant medications. However, they have limited efficacy and their onset of action is long, ranging between 2 to 6 weeks. During this period, hospitalization can become necessary, especially for severe MDE. It is crucial to improve the early effectiveness of treatments for these patients in order to alleviate their suffering, limit complications (suicidal risk), and reduce hospitalization durations (approximately 1000 euros per day). The efficacy of intravenous ketamine has been demonstrated in pharmaco-resistant depression but remains to be proven in non-pharmaco-resistant severe MDE. Additionally, PET imaging using \[11C\]UCB-J, which allows the in vivo study of synaptic density in the human brain, has shown significant decreases in synaptic density in unipolar patients with severe MDE. Furthermore, a single ketamine infusion was found to enhance synaptogenesis
CONDITIONS
Official Title
Early Effects of Ketamine vs Placebo With Venlafaxine in Severe Depression Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Current major depressive episode (MDE) in unipolar major depressive disorder diagnosed by DSM-5 criteria
- Hospitalized (open care) for this episode
- Minimum Hamilton Depression Rating Scale (HDRS) score of 24
- Indication for starting venlafaxine treatment
- Age between 18 and 65 years
- Signed free and informed consent
- Membership in a social security scheme
- For women of childbearing age, use of effective contraception throughout the study (methods listed in protocol)
You will not qualify if you...
- Treatment-resistant depressive episode (failure of at least two adequate antidepressant treatments)
- Depressive episode with psychotic features, psychotic disorder, or bipolar disorder
- Current substance use disorder (within past month), excluding tobacco
- Liver impairment with elevated liver enzymes beyond specified limits
- Severe kidney insufficiency (GFR <30 ml/min)
- Bradycardia (heart rate less than 55 bpm)
- Contraindications to ketamine including hypersensitivity, coma, CNS depression, certain neurological diseases, prolonged QTc interval, recent acute myocardial infarction, heart failure, ventricular arrhythmias, hypokalemia, epilepsy, uncontrolled hypertension, porphyria, history of stroke, or intracranial hypertension
- Contraindications to venlafaxine including hypersensitivity, certain hereditary conditions, unstable hypertension, or prior ineffectiveness or intolerance
- Use of venlafaxine or ketamine in the month before study
- Need for another antidepressant, MAOI, Millepertuis, or benzodiazepines (except cyamemazine)
- Any clinically significant illness or condition that could compromise safety
- Pregnancy or breastfeeding or planned pregnancy within three months
- Adult under legal guardianship or curatorship
- Participation in other interventional research involving the human body within exclusion periods
- Contraindications to [11C]UCB-J PET-MRI for ancillary study including pacemakers, implants, ferromagnetic objects, claustrophobia, and others as specified
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Psychiatry unit
Le Kremlin-Bicêtre, France, France, 94270
Actively Recruiting
2
EPS Barthélémy Durand
Étampes, France, 91152
Not Yet Recruiting
3
Bicetre Hospital - CRC
Le Kremlin-Bicêtre, France, 94250
Not Yet Recruiting
4
CEA/SHFJ
Orsay, France, 94401
Active, Not Recruiting
Research Team
R
Romain COLLE
CONTACT
E
Emmanuelle CORRUBLE
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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