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Completed

NCT Number: NCT01557712

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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centre hospitalier universitaire

Grenoble, 38000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ketamine venlafaxine

Drug

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

Venlafaxine

Drug

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

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

Acronym: KETADEP

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Mar 19, 2012
Registry last updated
Feb 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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