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Ketamine Infusions for Major Depression Disorder (Ketamie)

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ClinicalTrials.gov Identifier: NCT02219867
Recruitment Status : Unknown
Verified August 2014 by Dr. Revital Amiaz, Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : August 19, 2014
Last Update Posted : August 29, 2014
Sponsor:
Collaborator:
Tel Aviv University
Information provided by (Responsible Party):
Dr. Revital Amiaz, Sheba Medical Center

Brief Summary:

Ketamine has been safely used for induction and maintenance of anesthesia for decades and more recently has been used for chronic pain. Ketamine is a noncompetitive, high-affinity antagonist of the N-methyl-D-aspartate type glutamate receptor, with additional effects on dopamine and μ-opioid receptors. During the last 9 years several uncontrolled reports have been published, showing a rapid and impressive effect of ketamine in TRD patients (Berman, Cappiello et al. 2000; Zarate, Singh et al. 2006; Mathew, Murrough et al. 2010; Aan Het Rot, Zarate et al. 2012; Mathew, Shah et al. 2012; Murrough, Iosifescu et al. 2013). Recently three placebo-controlled trials showed that a single dose of sub-anesthetic, (0.5 mg/kg) slow intravenous (IV) ketamine improves depressive symptoms dramatically. Across studies, a clinically significant antidepressant response was maintained for up to 72 hours in 12 of 25 patients. Nonetheless, all but two patients relapsed <2 weeks post-ketamine (Zarate, Singh et al. 2006; aan Het Rot, Zarate et al. 2012). Rot et al. showed that repeated IV ketamine infusions prolongs the duration of improvement.

The investigators believe that the data presented above allows us to provide ketamine treatment here in the Sheba Medical Center for TRD patients.


Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Drug: Ketamine Not Applicable

Detailed Description:

Major depressive disorder (MDD) is one of the leading causes of disability worldwide (Collins, Patel et al. 2011). A substantial proportion of patients do not achieve adequate remission despite multiple antidepressant trials and augmentation strategies (Rush, Trivedi et al. 2006; Weissman, Pilowsky et al. 2006). Treatment-resistant major depression (TRD) is defined as an insufficient response to at least two adequate antidepressant trials (Rush, Trivedi et al. 2006). Many of these patients are referred to previous somatic treatment e.g. electroconvulsive therapy (ECT), rapid Transcranial Magnetic Stimulation (rTMS) and Vagal Nerve Stimulation (VNS), all of which have serious disadvantages and/or limited efficacy.

Ketamine has been safely used for induction and maintenance of anesthesia for decades and more recently has been used for chronic pain. Ketamine is a noncompetitive, high-affinity antagonist of the N-methyl-D-aspartate type glutamate receptor, with additional effects on dopamine and μ-opioid receptors. During the last 9 years several uncontrolled reports have been published, showing a rapid and impressive effect of ketamine in TRD patients (Berman, Cappiello et al. 2000; Zarate, Singh et al. 2006; Mathew, Murrough et al. 2010; Aan Het Rot, Zarate et al. 2012; Mathew, Shah et al. 2012; Murrough, Iosifescu et al. 2013). Recently three placebo-controlled trials showed that a single dose of sub-anesthetic, (0.5 mg/kg) slow intravenous (IV) ketamine improves depressive symptoms dramatically. Across studies, a clinically significant antidepressant response was maintained for up to 72 hours in 12 of 25 patients. Nonetheless, all but two patients relapsed <2 weeks post-ketamine (Zarate, Singh et al. 2006; aan Het Rot, Zarate et al. 2012). Rot et al. showed that repeated IV ketamine infusions prolongs the duration of improvement.

The investigators believe that the data presented above allows us to provide ketamine treatment here in the Sheba Medical Center for TRD patients.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Safety and Efficacy of Sub-anesthetic Ketamine Infusions as a Treatment for Patients Diagnosed With Resistant Major Depression
Study Start Date : August 2014
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: Ketamine
Active Comparator
Drug: Ketamine
Drug (including placebo)
Other Name: ketalar




Primary Outcome Measures :
  1. Montgomery Asberg Rating scale - MADRS [ Time Frame: 24 hours after treatment ]

Secondary Outcome Measures :
  1. Side effects monitoring [ Time Frame: Up to 4 hours after ketamine infustion ]
    Blood pressure monitoring Dissociative symptoms detection and description


Other Outcome Measures:
  1. Hamilston depression Rating Scale [ Time Frame: Up to 30 days from last treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Major Depressive disorder, chronic and/or recurrent of at least at moderate severity, determined as reflected by baseline scores of ≥32 on the Inventory of Depressive Symptomatology -Clinician rated IDS-C30
  • Patients with demonstrated insufficient response to ≥2 adequate antidepressant trials in the current episode

Exclusion Criteria:

  • Current psychotic or dissociative symptoms
  • Severe personality disorder with psychosis or dissociative symptoms
  • Lifetime history of psychotic mania
  • Substance use disorder
  • Current suicidal ideation
  • Uncontrolled elevated blood pressure, non-sinus rhythm, unstable ischemic heart disease, uncorrected hyper thyroidism, and for women, pregnancy or the initiation of or female hormonal treatment <3 months

Information from the National Library of Medicine

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): NCT02219867


Locations
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Israel
Sheba MC Not yet recruiting
Ramat Gan, Israel, 5265601
Contact: Revital Amiaz, Dr    972-35303436    revital.amiaz@sheba.health.gov.il   
Principal Investigator: Revital Amiaz, Dr         
Sponsors and Collaborators
Sheba Medical Center
Tel Aviv University

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Responsible Party: Dr. Revital Amiaz, Doctor, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02219867     History of Changes
Other Study ID Numbers: Sheba- Ketamine
First Posted: August 19, 2014    Key Record Dates
Last Update Posted: August 29, 2014
Last Verified: August 2014
Keywords provided by Dr. Revital Amiaz, Sheba Medical Center:
ketamine
MDD
Additional relevant MeSH terms:
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Ketamine
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
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