Ketamine Infusions for Major Depression Disorder

NCT ID: NCT02219867

Last Updated: 2014-08-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2017-08-31

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.

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.

Conditions

Depressive Disorder, Major

Keywords

ketamine; MDD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ketamine

Active Comparator

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: DRUG

Drug (including placebo)

Interventions

Ketamine

Drug (including placebo)

Intervention Type: DRUG

Other Intervention Names

ketalar

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tel Aviv University

OTHER

Sponsor Role: collaborator

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr. Revital Amiaz

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sheba MC

Ramat Gan, , Israel

Countries

Israel

Facility Contacts

Revital Amiaz, Dr

Role: primary

Other Identifiers

Sheba- Ketamine

Identifier Type: -

Identifier Source: org_study_id