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

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.

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

  • 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

Interventions

  • 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

Primary 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

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Grenoble
  • Provider of Information About this Clinical Study
    • Sponsor

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