Ketamine Infusions for Major Depression Disorder

NCT02219867 | Unknown DMC

• 1 other identifier: Sheba- Ketamine
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Disorder, Major

Keywords

ketamine; MDD

Outcome Measures

Primary Outcomes (1)

• Montgomery Asberg Rating scale - MADRS

  24 hours after treatment

Secondary Outcomes (1)

• Side effects monitoring

  Up to 4 hours after ketamine infustion

Other Outcomes (1)

• Hamilston depression Rating Scale

  Up to 30 days from last treatment

Study Arms (1)

Ketamine

EXPERIMENTAL

Active Comparator

Drug: Ketamine

Interventions

Ketamine DRUG

Drug (including placebo)

Also known as: ketalar

Ketamine

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheba Medical Center: lead
• Tel Aviv University: collaborator

Study Sites (1)

Sheba MC

Ramat Gan, 5265601, Israel

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: August 12, 2014
• First Posted: August 19, 2014
• Study Start: August 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: August 1, 2017
• Last Updated: August 29, 2014

Record last verified: 2014-08

Locations

IL (1)