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

Phase 1

• Conditions: Major depressive disorder with current severe major depressive episode; MedDRA version: 21.1Level: LLTClassification code: 10045543Term: Unipolar depression Class: 10037175; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: CTIS2023-506597-12-00
• Lead Sponsor: Assistance Publique Hopitaux De Paris

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-11
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion 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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified