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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
EU CTIS ID: 2023-506597-12-00
What this study is testing
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
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
- Participating in other interventional research involving the human body or within the exclusion period following previous research involving the human body, if applicable
- Social insurance
- 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.
See the full eligibility criteria
- 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
- 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
- Participating in other interventional research involving the human body or within the exclusion period following previous research involving the human body, if applicable
- Social insurance
- 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.
- 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
- Need to maintain another antidepressant, MAOI, Millepertuis or benzodiazepines (cyamemazine is permitted)
- 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
- Adult under guardianship, curatorship, or safeguard of justice
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.