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.
Full Title of Study: “Estimate the Efficiency of the Association of an Injection of Ketamine and the Venlafaxine in the Severe Major Depressive Disorder for Six Weeks.”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: Triple (Participant, Care Provider, Investigator)
- Study Primary Completion Date: January 2017
- Drug: ketamine venlafaxine
- 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
- Drug: Venlafaxine
- 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
Arms, Groups and Cohorts
- Experimental: Ketamine+venlafaxine
- one injection of 0.5 mg/kg of kentamine the first day plus venlafaxine (150-375 mg day) during 6 weeks
- Active Comparator: venlafaxine
- venlafaxine (150-375 mg day) during 6 weeks
Clinical Trial Outcome Measures
- Depressive state
- Time Frame: 6 weeks
- 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.
Participating in This Clinical Trial
- 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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- University Hospital, Grenoble
- Provider of Information About this Clinical Study
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