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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by University Hospital, Grenoble
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01557712
First received: March 15, 2012
Last updated: March 16, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Drug: ketamine venlafaxine
Drug: Venlafaxine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Estimate the Efficiency of the Association of an Injection of Ketamine and the Venlafaxine in the Severe Major Depressive Disorder for Six Weeks.

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • Depressive state [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

    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 ≤ 7.


Estimated Enrollment: 40
Study Start Date: February 2012
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ketamine+venlafaxine
one injection of 0.5 mg/kg of kentamine the first day plus venlafaxine (150-225 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 D5: 75 mg of venlafaxine
  • D5 to D28: 150 mg per day of venlafaxine
  • D28 to D42: 150 mg daily of venlafaxine or 225 mg per day of venlafaxine if patient not responder to D28
Active Comparator: venlafaxine 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 D5: 75 mg of venlafaxine
  • D5 to D28: 150 mg per day of venlafaxine
  • D28 to D42: 150 mg daily of venlafaxine or 225 mg per day of venlafaxine if patient not responder to D28

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;
  • Major depressive episode with psychotic symptoms;
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01557712

Contacts
Contact: JEROME HOLTZMANN, MD 33 683 50 09 78 jholtzmann@chu-grenoble.fr
Contact: THIERRY BOUGEROL, MD, PhD 33 476765411 tbougerol@chu-grenoble.fr

Locations
France
Centre hospitalier universitaire Recruiting
Grenoble, France, 38000
Contact: JEROME HOLTZMANN, MD    33 6 83 50 09 78    jholtzmann@chu-grenoble.fr   
Sponsors and Collaborators
University Hospital, Grenoble
  More Information

No publications provided

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01557712     History of Changes
Other Study ID Numbers: 1129
Study First Received: March 15, 2012
Last Updated: March 16, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Disease
Mood Disorders
Mental Disorders
Behavioral Symptoms
Pathologic Processes
Venlafaxine
Ketamine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants

ClinicalTrials.gov processed this record on September 30, 2014