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

Phase 3

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: ketamine venlafaxine; Drug: Venlafaxine

• Registration Number: NCT01557712
• Lead Sponsor: University Hospital, Grenoble

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-15
• Study First Submitted QC: 2012-03-16
• Study First Posted: 2012-03-19
• Status Verified: 2017-01
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Last Update Submitted: 2017-02-23
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ketamine+venlafaxine	ketamine venlafaxine	one injection of 0.5 mg/kg of kentamine the first day plus venlafaxine (150-375 mg day) during 6 weeks
venlafaxine	Venlafaxine	venlafaxine (150-375 mg day) during 6 weeks

Primary Outcome Measures

Name	Time	Method
Depressive state	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.

Trial Locations

Locations (1)

Centre hospitalier universitaire; 🇫🇷 Grenoble, France