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
Key facts
- Where
- Etampes Cedex, Le Kremlin Bicetre Cedex és Orsay Cedex, FranciaországSee the 3 sites
- Phase
- 3. fázis
Could this be for you?
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 Franciaország
- Etablissement Public De Sante Barthelemy DurandEtampes Cedex, FranciaországTaking people
- Bicetre HospitalLe Kremlin Bicetre Cedex, FranciaországTaking people
- Commissariat A L'energie Atomique Et Aux Energies AlternativesOrsay Cedex, FranciaországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Assistance Publique Hopitaux De Paris
- Trial code
- EU 2023-506597-12-00
- Record updated
- 2026. augusztus 4.
- Original description
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 changesRead full original descriptionShow less
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 »
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
Inclusion: 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.
Exclusion: 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.