NCT01557712CompletedPhase 3
Estimate the Efficiency of the Association of an Injection of Ketamine and the Venlafaxine in the Severe Major Depressive Disorder for Six Weeks.
University Hospital, Grenoble1 site in 1 country25 target enrollmentStarted: March 2012Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Depressive state
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Ketamine+venlafaxine
Experimental
one injection of 0.5 mg/kg of kentamine the first day plus venlafaxine (150-375 mg day) during 6 weeks
Intervention: ketamine venlafaxine (Drug)
venlafaxine
Active Comparator
venlafaxine (150-375 mg day) during 6 weeks
Intervention: Venlafaxine (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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