Clinical TrialMajor Depressive Disorder (MDD)KetaminePlaceboKetaminePlaceboCompleted

A Study of Ketamine in Patients With Treatment-resistant Depression

Randomized, double-blind, placebo-controlled, parallel Phase II study (n=68) comparing IV ketamine 0.5 mg/kg given 2 or 3 times weekly for 4 weeks in patients with treatment-resistant major depressive disorder to determine optimal dosing frequency.

Target Enrollment
68 participants
Study Type
Phase II interventional
Design
Randomized, double Blind

Detailed Description

Double-blind, randomized, parallel-group Phase II trial comparing intravenous ketamine 0.50 mg/kg administered two or three times per week versus matching placebo over a 4-week double-blind treatment phase (Day 1 to Day 29).

Each patient undergoes screening up to 4 weeks, a 4-week double-blind treatment period and a 3-week post-treatment follow-up; key outcomes include antidepressant response and safety/tolerability. Patients were inpatient or agreed to be admitted on dosing days.

Study Protocol

Preparation

sessions

Dosing

12 sessions

Integration

sessions

Study Arms & Interventions

Ketamine 3x/week

experimental

IV ketamine 0.50 mg/kg, three times weekly for 4 weeks

Interventions

  • Ketamine0.5 mg/kg
    via IV• three times weekly• 12 doses total

Placebo 3x/week

inactive

IV placebo infusion, three times weekly for 4 weeks

Interventions

  • Placebo
    via IV• three times weekly• 12 doses total

Ketamine 2x/week

experimental

IV ketamine 0.50 mg/kg, two times weekly for 4 weeks

Interventions

  • Ketamine0.5 mg/kg
    via IV• two times weekly• 8 doses total

Placebo 2x/week

inactive

IV placebo infusion, two times weekly for 4 weeks

Interventions

  • Placebo
    via IV• two times weekly• 8 doses total

Participants

Ages
18 – 64
Sexes
Male & Female

Inclusion Criteria

  • Be medically stable on the basis of clinical laboratory tests performed at screening
  • Meet diagnostic criteria for recurrent major depressive disorder (MDD), without psychotic features
  • Have a history of inadequate response, ie treatment was not successful, to at least 1 antidepressant
  • Have an Inventory of Depressive Symptoms-Clinician rated, 30 item (IDS-C30) total score >= 40 at screening and predose at Day 1
  • Inpatient or agreed to be admitted to the clinic on each dosing day

Exclusion Criteria

  • Has uncontrolled hypertension
  • Has a history of, or current signs and symptoms of diseases, infections or conditions that in the opinion of the investigator, would make participation not be in the best interest (eg, compromise the well-being) of the patient or that could prevent, limit, or confound the protocol-specified assessments
  • Has known allergies, hypersensitivity, or intolerance to ketamine or its excipients
  • Is unable to read and understand the consent forms and patient reported outcomes, complete study-related procedures, and/or communicate with the study staff

Study Details

Locations

Unknown facility — Birmingham, Alabama, United States
Unknown facility — Little Rock, Arkansas, United States
Unknown facility — Centennial, Colorado, United States
Unknown facility — Hartford, Connecticut, United States
Unknown facility — New Haven, Connecticut, United States
Unknown facility — Atlanta, Georgia, United States
Unknown facility — Rockville, Maryland, United States
Unknown facility — Marlton, New Jersey, United States
Unknown facility — New York, New York, United States
Unknown facility — Allentown, Pennsylvania, United States
Unknown facility — Charleston, South Carolina, United States
Unknown facility — Dallas, Texas, United States
Unknown facility — Salt Lake City, Utah, United States

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