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Study identifier: NCT06508710 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Early Effects of Ketamine vs Placebo With Venlafaxine in Severe Depression Patients

Condition: Major Depressive Episode  ·  Sponsor: Assistance Publique - Hôpitaux de Paris

PhasePhase 3
Planned participants60
Who can joinAll sexes, 18 Years to 65 Years
Healthy volunteersNo

About this study

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

This description comes directly from the study's public registry record.

Talk to the study team

Romain COLLE  ·  +33145212524  ·  romain.colle@aphp.fr

Emmanuelle CORRUBLE  ·  +33145212524  ·  emmanuelle.corruble@aphp.fr

Always discuss trial participation with your own doctor first.

Locations (4)

Psychiatry unitLe Kremlin-Bicêtre, France, FranceRecruiting
EPS Barthélémy DurandÉtampes, FranceNot Yet Recruiting
Bicetre Hospital - CRCLe Kremlin-Bicêtre, FranceNot Yet Recruiting
CEA/SHFJOrsay, FranceActive Not Recruiting

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Source record: clinicaltrials.gov/study/NCT06508710