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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)
This study has been completed.
Sponsor:
University Hospital, Grenoble
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01557712
First received: March 15, 2012
Last updated: February 23, 2017
Last verified: January 2017
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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 Intervention Model: Single Group Assignment Masking: Triple (Participant, Care Provider, 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:
Drug Information available for:
Ketamine hydrochloride
Ketamine
Venlafaxine
Venlafaxine hydrochloride
U.S. FDA Resources
Further study details as provided by University Hospital, Grenoble:
Primary Outcome Measures:
- 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.
| Enrollment: | 25 |
| Actual Study Start Date: | March 2012 |
| Study Completion Date: | January 2017 |
| Primary Completion Date: | January 2017 (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 (150-375 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:
|
|
Active Comparator: venlafaxine
venlafaxine (150-375 mg day) during 6 weeks
|
Drug: Venlafaxine
After a washout period of 7 days of psychotropic medications with the exception of cyamemazine and hydroxyzine:
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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;
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01557712
Please refer to this study by its ClinicalTrials.gov identifier: NCT01557712
Locations
| France | |
| Centre hospitalier universitaire | |
| Grenoble, France, 38000 | |
Sponsors and Collaborators
University Hospital, Grenoble
More Information
| 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: | February 23, 2017 |
Additional relevant MeSH terms:
|
Disease Depressive Disorder Depression Depressive Disorder, Major Pathologic Processes Mood Disorders Mental Disorders Behavioral Symptoms Ketamine Venlafaxine Hydrochloride Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anesthetics, Dissociative |
Anesthetics, Intravenous Anesthetics, General Anesthetics Central Nervous System Depressants Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin and Noradrenaline Reuptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs |
ClinicalTrials.gov processed this record on September 21, 2017