Clinical TrialMajor Depressive Disorder (MDD)KetamineUnknown status

Ketamine for Treatment Resistant MDD

This study aims to openly test the long-term safety, tolerability and effectiveness of repeated administration of IM/SC ketamine for treatment resistant MDD.

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

Detailed Description

Open-label, single-group study evaluating repeated, individually tailored intramuscular or subcutaneous ketamine (0.3–1.5 mg/kg; up to 3×/week) in treatment-resistant major depressive disorder.

Primary aims are safety and tolerability; secondary assessments include antidepressant effectiveness, cognitive effects using the Neurotrax battery, and exploration of optimal dose, frequency and duration.

Study Arms & Interventions

MDD

experimental

Treatment-resistant patients treated with multiple IM/SC ketamine doses (individually tailored; 0.3–1.5 mg/kg).

Interventions

  • Ketamine0.3 - 1.5 mg/kg
    via IM• up to 3/week

    IM or SC; individualized dosing 0.3–1.5 mg/kg; up to 3x/week; repeated administration

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Diagnosed with unipolar/bipolar depression with MADRS Score >= 20
  • Inadequate response to >= 3 adequate treatment trials (>=2 trials in the present episode)
  • If on psychopharmacological treatment, it should be stable since 4 weeks prior to enrollment
  • QTc within normal limits

Exclusion Criteria

  • Exclusion Criteria:
  • Hypersensitivity to ketamine
  • Other major psychiatric diagnosis
  • High suicidality
  • Unstable physical illness
  • Status post cerebrovascular accident (CVA) / brain space-occupying lesion (SOL)
  • Pregnant or breastfeeding women
  • Illicit drug/alcohol abuse during last year
  • History of ketamine abuse

Study Details

  • Status
    Unknown status
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment20 participants
  • Timeline
    Start: 2018-09-01
    End: 2020-12-30
  • Compound
    Ketamine
  • Topic
    Major Depressive Disorder (MDD)

Locations

Hadassah Hebrew University Medical Center — Jerusalem, Israel

Your Library