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Taking people in FrancePhase 3

Tests ketamine added to venlafaxine for severe depression in hospitalized adults

Tests ketamine or a placebo added to venlafaxine in hospitalized adults with severe depression.

Key facts

Who runs it
Assistance Publique Hopitaux De Paris
Where
Etampes Cedex, Le Kremlin Bicetre Cedex, and Orsay Cedex, FranceSee the 3 sites
Registry title
Early efficacy of ketamine compared to placebo, in add-on therapy of venlafaxine for inpatients with severe unipolar major depressive episodes: a double blind randomized controlled trial
Status
Recruiting
Phase
Phase 3
People taking part
60 people, planned
Started
20 Nov 2024
Expected to end
11 Jul 2028
Type of study
Interventional
Record updated
4 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults hospitalized for a severe episode of major depression who need to start venlafaxine. It compares ketamine and placebo added to venlafaxine.

Age
18 to 65 years (the registry lists a maximum age of 64 years)
Sex
All sexes can join.
Disease stage
A current major depressive episode with major depressive disorder, severe, with a HDRS score of at least 24, in hospital care, with an indication to start venlafaxine.
Earlier treatment
Cannot have taken venlafaxine or ketamine in the month before joining. Cannot have failed at least two proper treatments from two different antidepressant classes.

Main reasons for not taking part

  • Depression with psychotic features, psychotic disorder or bipolar disorder
  • Current substance use disorder (less than 1 month), not counting tobacco
  • Liver or severe kidney problems
  • Contraindication to ketamine or venlafaxine, such as long QT, recent heart attack, epilepsy or uncontrolled high blood pressure
  • Pregnant or breast-feeding, or planning pregnancy within three months

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • Current MDE in the context of Major Depressive Disorder (DSM-5 criteria), hospitalized (open care) for this episode, with a minimum HDRS score of 24 and in the context of an indication for the introduction of venlafaxine treatment
  • Patient aged between 18 and 65
  • Signed free and informed consent
  • Membership of a social security scheme
  • For women of childbearing age, effective contraception throughout study participation

Who cannot take part

  • Participating in other interventional research involving the human body or within the exclusion period following previous research involving the human body, if applicable
  • Contraindication to venlafaxine (hypersensitivity to venlafaxine or excipients, unstable hypertension, no indication for venlafaxine treatment in clinician's opinion due to ineffectiveness or tolerability of previous venlafaxine treatment)
  • Current or previous treatment with venlafaxine or ketamine in the month prior to study inclusion
  • Pregnant or breast-feeding patients (women of childbearing potential must have a negative urine or blood test for human chorionic gonadotropin prior to trial entry). Planned pregnancy within three months of enrolment
  • Criteria relating to associated pathologies entailing particular risks: pharmaco-resistant MDE (failure of at least two properly conducted treatments with two different antidepressant treatment classes), MDE with psychotic features, psychotic disorder, bipolar disorder, current (<1 month) substance use disorder (excluding tobacco
  • Liver impairment (AST and/or ALT > 3 ULN, PAL and/or GGT and/or bilirubin > 2 ULN)
  • Severe renal insufficiency (GFR <30ml/min with Cockcroft's formula)
  • Contraindication to ketamine : Hypersensitivity to active substance or excipients, comatose state, central nervous system (CNS) depression, Parkinson's disease, Lewy body dementia, progressive supranuclear palsy, known prolongation of the QTc interval (>450ms for men and >470ms for women) or congenital long QT syndrome, recent acute myocardial infarction, uncompensated heart failure, history of ventricular arrhythmias or torsades de pointes, uncorrected hypokalemia (K+ < 3. 5 mmol/l), epilepsy, uncontrolled hypertension, porphyria
  • Social insurance
  • Need to maintain another antidepressant, MAOI, Millepertuis or benzodiazepines (cyamemazine is permitted)
  • Adult under guardianship, curatorship, or safeguard of justice

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 64 years old?

Where in France

  • Etablissement Public De Sante Barthelemy DurandEtampes Cedex, FranceTaking people
  • Bicetre HospitalLe Kremlin Bicetre Cedex, FranceTaking people
  • Commissariat A L'energie Atomique Et Aux Energies AlternativesOrsay Cedex, FranceTaking people

About the trial

What the trial wants to find out

Objective For the main Study to compare early efficacy at day 7 on depressive symptoms of intravenous ketamine versus placebo on add on to venlafaxine in patients hospitalized for severe major depressive episode Objectives for ancillary study 1) To compare synaptic density changes assessed by PET-MRI before (d0) and after (d14) early add on treatment of ketamine or placebo in patients hospitalized for severe major depressive episode. 2) To assess whether clinical improvement after ketamine correlates with synaptic density changes

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
MOODBOOSTER« Early efficacy of ketamine compared to placebo, in add-on therapy of venlafaxine for inpatients with severe unipolar major depressive episodes: a double blind randomized controlled trial »
Plain-language title
Tests ketamine added to venlafaxine for severe depression in hospitalized adultsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Fit questions
Built from 2023-506597-12-00, who can take part
Record updated
4 August 2026