Major Depressive Disorder
Conditions
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.
Interventions
DRUGketamine 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
DRUGVenlafaxine
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
Sponsors
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
France
Outcome results
None listed