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

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

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: ketamine venlafaxine; Drug: Venlafaxine

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38000
    • Centre Hospitalier Universitaire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ketamine+venlafaxine; one injection of 0.5 mg/kg of kentamine the first day plus venlafaxine (150-375 mg day) during 6 weeks	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
Active Comparator: venlafaxine; venlafaxine (150-375 mg day) during 6 weeks	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive state	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.	6 weeks

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2012
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: March 15, 2012
• First Submitted That Met QC Criteria: March 16, 2012
• First Posted (Estimate): March 19, 2012

Study Record Updates

• Last Update Posted (Actual): February 24, 2017
• Last Update Submitted That Met QC Criteria: February 23, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Antidepressive Agents, Second-Generation; Serotonin and Noradrenaline Reuptake Inhibitors; Ketamine; Venlafaxine Hydrochloride
• Other Study ID Numbers: 1129