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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Major Depressive Disorder | Drug: ketamine venlafaxine Drug: Venlafaxine | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 25 participants |
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. |
Actual Study Start Date : | March 2012 |
Actual Primary Completion Date : | January 2017 |
Actual Study Completion Date : | January 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Ketamine+venlafaxine
one injection of 0.5 mg/kg of kentamine the first day plus venlafaxine (150-375 mg day) during 6 weeks
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Drug: ketamine venlafaxine
After a washout period of 7 days of psychotropic medications with the exception of cyamemazine and hydroxyzine:
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Active Comparator: venlafaxine
venlafaxine (150-375 mg day) during 6 weeks
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Drug: Venlafaxine
After a washout period of 7 days of psychotropic medications with the exception of cyamemazine and hydroxyzine:
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- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01557712
France | |
Centre hospitalier universitaire | |
Grenoble, France, 38000 |
Responsible Party: | University Hospital, Grenoble |
ClinicalTrials.gov Identifier: | NCT01557712 History of Changes |
Other Study ID Numbers: |
1129 |
First Posted: | March 19, 2012 Key Record Dates |
Last Update Posted: | February 24, 2017 |
Last Verified: | January 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 |