Actively Recruiting
Early Efficacy of Ketamine Compared With Placebo as Add-On Therapy With Venlafaxine in Adults Hospitalized for Severe Unipolar Depression
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-09-03
60
Participants Needed
4
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Major depressive disorder is a leading cause of disability worldwide, with current treatments like antidepressants often taking 2 to 6 weeks to show effects. This delay can lead to hospitalization for severe major depressive episodes (MDE). Researchers are evaluating the early effects of intravenous ketamine, alongside standard venlafaxine treatment, in patients hospitalized with severe unipolar depression to potentially improve early treatment response and reduce risks such as suicidal ideation and long hospital stays. Participants in this study will receive either three doses of intravenous ketamine or placebo on days 1, 4, and 7, in addition to their usual venlafaxine treatment. The study compares ketamine to placebo as an add-on therapy to venlafaxine during this early treatment phase. The study is randomized and quadruple-blinded to assess the efficacy and safety of ketamine in this setting. During the study, participants will be closely monitored for depressive symptoms using tools like the Hamilton Depression Rating Scale (HDRS), Beck Depression Inventory (BDI), and Clinical Global Impression (CGI) at multiple time points up to 42 days. Safety parameters such as blood pressure, heart rate, respiratory rate, and side effects like nausea and dissociation will also be tracked. Additional assessments include hospitalization duration, suicidal ideation, anxiolytic use, biomarkers, and PET imaging in a subset of patients. The total follow-up period extends to 42 days after treatment initiation.
CONDITIONS
Brief Title
Early Effects of Ketamine vs Placebo With Venlafaxine in Severe Depression Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years
- Current major depressive episode (MDE) within unipolar major depressive disorder diagnosed by DSM-5 criteria
- Hospitalized (open care) for this depressive episode
- Minimum Hamilton Depression Rating Scale (HDRS) score of 24
- Indication for starting venlafaxine treatment
- Signed free and informed consent
- Membership in a social security scheme
- Women of childbearing potential must use effective contraception throughout the study
You will not qualify if you...
- Treatment-resistant depression (failure of at least two antidepressant classes)
- Depression with psychotic features or psychotic disorders
- Bipolar disorder
- Substance use disorder within past month (excluding tobacco)
- Significant liver impairment or severe kidney insufficiency
- Bradycardia (heart rate less than 55 bpm)
- Contraindications to ketamine or venlafaxine
- Prior venlafaxine or ketamine use in past month
- Need to maintain other antidepressants or contraindicated medications
- Pregnant or breastfeeding women or pregnancy planned within 3 months
- Adults under guardianship or legal protection
- Participation in other interventional research involving the human body recently
- Contraindications to PET-MRI for ancillary study such as pacemakers, metal implants, claustrophobia
- Any other clinically significant illness or anomaly affecting safety
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 week
Participants receive intravenous ketamine or placebo as add-on therapy with venlafaxine over one week.
3 visits (in-person) on Days 1, 4, and 7
Duration - 5 weeks
Participants are monitored for clinical improvement and treatment tolerance for 5 weeks after treatment.
Visits at Days 14, 28, and 42
Trial Site Locations
Total: 4 locations
1
Psychiatry unit
Le Kremlin-Bicêtre, France, France, 94270
Actively Recruiting
2
EPS Barthélémy Durand
Étampes, France, 91152
Not Yet Recruiting
3
Bicetre Hospital - CRC
Le Kremlin-Bicêtre, France, 94250
Not Yet Recruiting
4
CEA/SHFJ
Orsay, France, 94401
Active, Not Recruiting
Research Team
R
Romain COLLE
E
Emmanuelle CORRUBLE
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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