Estimate the Efficiency of the Association of an Injection of Ketamine and the Venlafaxine in the Severe Major Depressive Disorder for Six Weeks

University Hospital, Grenoble25 enrolled

Overview

The objective of this study is to evaluate the effectiveness of ketamine (infusion of 0.5mg/kg) and venlafaxine compared to the use of venlafaxine alone in the treatment of major depression (MADRS score ≥ 20 ) to six weeks of treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Major Depressive Disorder

Interventions

ketamine venlafaxineDRUG

After a washout period of 7 days of psychotropic medications with the exception of cyamemazine and hydroxyzine: * Intravenous injection on day 0 to 0.5 mg / kg of ketamine * D0 to D4: 75 mg of venlafaxine * D4 to D14: 150 mg per day of venlafaxine * D14 to D42: 150 mg daily of venlafaxine to 375 mg per day of venlafaxine if patient not responder

VenlafaxineDRUG

After a washout period of 7 days of psychotropic medications with the exception of cyamemazine and hydroxyzine: * Intravenous injection on day 0 to 0.5 mg / kg of placebo (saline serum) * D0 to D4: 75 mg of venlafaxine * D4 to D14: 150 mg per day of venlafaxine * D14 to D42: 150 mg daily of venlafaxine to 375 mg per day of venlafaxine if patient not responder

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients aged 18 or over, * Introducing a single depressive episode or recurrent unipolar * Responding to the diagnosis of severe major depressive episode according to DSM IV (Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition): MADRS score ≥ 20, * absence of treatment with ketamine for analgesia or anesthesia during the last 6 months * Affiliate (or beneficiary) to a social security system * Informed consent signed Exclusion Criteria: * Contraindication to ketamine administration or treatment with venlafaxine; * Failure of treatment with venlafaxine in the current episode (as low as 150 mg for 15 days); * Axis I diagnosis according to DSM IV bipolar disorder (type I, II or III), schizoaffective disorder, schizophrenia, alcohol and other toxic or weaned for at least 6 months; * Current Episode resistant stage V according to the classification of Thase and Rush (failed a course of bilateral ECT); * Major depressive episode with severity criteria (significant risk of suicide is a MADRS score ≥ 5-SI; decubitus complications, intravenous hydration); * episode currently being treated with fluoxetine; * Patients hospitalized without their consent or measure of legal protection (guardianship, curatorship); * Affection Organic likely to affect cognitive abilities and brain structures (eg, HIV, MS, lupus, Parkinson's disease, epilepsy, dementia ...) or decompensation; * Pregnancy or breastfeeding underway.

Locations (1)

Centre hospitalier universitaire

Grenoble, France

Outcomes

Primary Outcomes

Depressive state

Assessment of depression by MADRS defining six weeks: * the state of clinical response defined by a MADRS score less than 50% in MADRS score at baseline initial set. * the state of clinical remission is defined by obtaining a MADRS score ≤ 8.

Time frame: 6 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.