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

• ClinicalTrials.gov Identifier: NCT01557712
• Recruitment Status: Completed
• First Posted: March 19, 2012
• Last Update Posted: February 24, 2017
• Sponsor: University Hospital, Grenoble
• Information provided by (Responsible Party): University Hospital, Grenoble

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Major Depressive Disorder	Drug: ketamine venlafaxine; Drug: Venlafaxine	Phase 3

Study Design

• 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

Arms and Interventions

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	Drug: ketamine 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
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: 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

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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
• First Posted: March 19, 2012
• Last Update Posted: February 24, 2017
• Last Verified: January 2017

Additional relevant MeSH terms:

Depressive Disorder; Depression; Depressive Disorder, Major; 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