Clinical TrialMajor Depressive Disorder (MDD)KetamineUnknown status

Ketamine Infusions for Major Depression Disorder

Single-group TRD study (n=10) providing ketamine infusions at Sheba Medical Center for treatment-resistant major depression.

Target Enrollment
10 participants
Study Type
Phase NA interventional
Design
Non-randomized

Detailed Description

Ketamine, an NMDA antagonist with rapid antidepressant effects, has shown rapid improvement in TRD in prior uncontrolled and controlled studies; single subanaesthetic IV doses (0.5 mg/kg) produce responses lasting up to 72 hours in many patients.

This single-group study offers IV ketamine infusions to patients with treatment-resistant major depression at Sheba Medical Center, following published protocols; safety and clinical response will be monitored.

Study Arms & Interventions

Ketamine

experimental

Single-group ketamine infusions for TRD

Interventions

  • Ketamine
    via IV• per clinical protocol

    IV ketamine infusions; dose per protocol (not specified in registry)

Participants

Ages
18 – 90
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Diagnosis of Major Depressive Disorder, chronic and/or recurrent of at least moderate severity, reflected by baseline IDS-C30 score ≥32
  • Insufficient response to ≥2 adequate antidepressant trials in the current episode

Exclusion Criteria

  • 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 hyperthyroidism, and for women, pregnancy or initiation of female hormonal treatment <3 months

Study Details

  • Status
    Unknown status
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment10 participants
  • Timeline
    Start: 2014-01-08
    End: 2017-01-08
  • Compound
    Ketamine
  • Topic
    Major Depressive Disorder (MDD)

Locations

Sheba MC — Ramat Gan, Israel

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