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

• Status: Completed
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Grenoble
• Treatments: Ketamine; Venlafaxine Hydrochloride

Criteria

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.