CompletedPhase 3ketamine
Estimate the Efficiency of the Association of an Injection of Ketamine and the Venlafaxine in the Severe Major Depressive Disorder for Six Weeks
Sponsored by University Hospital, Grenoble
NCT ID
NCT01557712
Target Enrollment
25 participants
Start Date
2012-03
Est. Completion
2017-01
About This Study
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.
Conditions Studied
Interventions
- •ketamine venlafaxine
- •Venlafaxine
Eligibility
Age:18 Years - N/A
Healthy Volunteers:No
View full eligibility 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.
Study Locations (1)
Centre hospitalier universitaire
Grenoble, France