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Compares treatment options for Major Depressive Episode
Official title Early Effects of Ketamine vs Placebo With Venlafaxine in Severe Depression Patients
ClinicalTrials.gov ID: NCT06508710
What this study is testing
What is Ketamine?
Ketamine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for major depressive episode.
Also referred to as Ketamine+Venlafaxine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Unipolar major depressive disorder is the leading cause of disability worldwide. The most commonly used treatments for major depressive episodes (MDE) are antidepressant medications.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Current MDE in the context of unipolar major depressive disorder (DSM-5 criteria), hospitalized (open care) for this episode, with a minimum HDRS...
- 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.\ (\ Combined hormonal contraception (containing estrogen and...
You likely can't join if
- Criteria relating to associated pathologies entailing particular risks: pharmaco-resistant CDE (failure of at least two properly conducted treatments...
- 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).
- Bradycardia less than 55 beats per minute.
- Contraindication to ketamine : Hypersensitivity to active substance or excipients, comatose state, central nervous system (CNS) depression...
- Contraindication to venlafaxine (hypersensitivity to venlafaxine or excipients, are hereditary conditions of fructose intolerance, glucose-galactose...
See the full eligibility criteria
- Current MDE in the context of unipolar 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...
- 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.\ (\ Combined hormonal contraception (containing estrogen and progestin) associated with ovulation inhibition: (oral, intravaginal...
- Criteria relating to associated pathologies entailing particular risks: pharmaco-resistant CDE (failure of at least two properly conducted treatments with two different antidepressant treatment classes), CDE with...
- 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).
- Bradycardia less than 55 beats per minute.
- 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...
- Contraindication to venlafaxine (hypersensitivity to venlafaxine or excipients, are hereditary conditions of fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase-isomaltase deficiency, unstable...
- 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). Or potential drug interactions in case of recent cessation of these treatments (based on the Summary of Product...
- Any other unspecified reason (clinically significant illness or anomaly) which, in the opinion of the investigator or the sponsor, could compromise the safety of the participant.
- 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
- Participating in other treatment research involving the human body or within the exclusion period following previous research involving the human body, if applicable.
- Social insurance Additional criteria for inclusion in the ancillary study : \- Contraindications to [11C]UCB-J PET-MRI
- Absolute contraindications: Pacemaker or neurosensorial stimulator or implantable defibrillator; clip on a brain aneurysm or vascular malformation; intraocular or intracerebral ferromagnetic foreign body; prostheses or...
- Relative contraindications: Dental prostheses and orthodontic material; certain intrauterine devices; certain tattoos; certain transdermal patch implants; certain metal implants far from the examined area. (The...
The study team makes the final eligibility decision.
Where it's taking place
- Le Kremlin-Bicêtre, France, France
- Étampes, France
- Le Kremlin-Bicêtre, France
- Orsay, France
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Le Kremlin-Bicêtre, France, France; Étampes, France; Le Kremlin-Bicêtre, France; Orsay, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.