RecruitingPhase 3NCT06508710

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

Early Efficacy of Ketamine Compared With Placebo as Adjunctive Therapy With Venlafaxine in Severely Unipolar Depressed Inpatients


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

60 participants

Start Date

Oct 20, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a low-dose infusion of ketamine given at the start of treatment can speed up relief of severe depression in hospitalized patients who are also being started on venlafaxine (a standard antidepressant). The study compares ketamine against a placebo infusion, with both groups also receiving venlafaxine. **You may be eligible if...** - You are between 18 and 65 years old - You have been hospitalized for a severe episode of major depression (not bipolar depression) with a high depression score - Your doctors have decided to start you on venlafaxine as treatment - You have signed informed consent and have health insurance - If you are a woman of childbearing age, you are using effective contraception **You may NOT be eligible if...** - You have bipolar disorder, schizophrenia, or a personality disorder - You have a history of substance abuse or dependence - You are currently using certain other psychiatric medications that cannot be stopped - You are pregnant or breastfeeding - You have severe heart, liver, or kidney disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKetamine

Patients randomized in this group will receive an intravenous ketamine in addition to venlafaxine for one week (on Days 1, 4 and 7)

DRUGPlacebo

Patients randomized in this group will receive an intravenous placebo in addition to venlafaxine for one week (on Days 1, 4 and 7)


Locations(4)

Psychiatry unit

Le Kremlin-Bicêtre, France, France

EPS Barthélémy Durand

Étampes, France

Bicetre Hospital - CRC

Le Kremlin-Bicêtre, France

CEA/SHFJ

Orsay, France

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NCT06508710


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