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

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ClinicalTrials.gov Identifier: NCT01557712
Recruitment Status : Completed
First Posted : March 19, 2012
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Tracking Information
First Submitted Date  ICMJE March 15, 2012
First Posted Date  ICMJE March 19, 2012
Last Update Posted Date February 24, 2017
Actual Study Start Date  ICMJE March 2012
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 16, 2012)
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 ≤ 7.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Estimate the Efficiency of the Association of an Injection of Ketamine and the Venlafaxine in the Severe Major Depressive Disorder for Six Weeks
Official Title  ICMJE Estimate the Efficiency of the Association of an Injection of Ketamine and the Venlafaxine in the Severe Major Depressive Disorder for Six Weeks.
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Ketamine+venlafaxine
    one injection of 0.5 mg/kg of kentamine the first day plus venlafaxine (150-375 mg day) during 6 weeks
    Intervention: Drug: ketamine venlafaxine
  • Active Comparator: venlafaxine
    venlafaxine (150-375 mg day) during 6 weeks
    Intervention: Drug: Venlafaxine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 23, 2017)
25
Original Estimated Enrollment  ICMJE
 (submitted: March 16, 2012)
40
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01557712
Other Study ID Numbers  ICMJE 1129
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University Hospital, Grenoble
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Hospital, Grenoble
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital, Grenoble
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP