UnknownN/Aketamine

Ketamine Infusions for Major Depression Disorder

Sponsored by Sheba Medical Center

NCT ID
NCT02219867
Target Enrollment
10 participants
Start Date
2014-08
Est. Completion
2017-08

About This Study

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 Studied

Depressive Disorder, Major

Interventions

  • Ketamine

Eligibility

Age:18 Years - 90 Years
Healthy Volunteers:No
View full 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

Study Locations (1)

Sheba MC
Ramat Gan, Israel

This trial is not recruiting

This study is currently not accepting new participants.

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Data Source
ClinicalTrials.gov

Last updated from source

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