Clinical TrialTreatment-Resistant Depression (TRD)KetamineKetaminePlaceboWithdrawn

Ketamine Frequency Treatment for Major Depressive Disorder

This randomized clinical trial will examine the frequency of treatment with ketamine in patients with treatment-resistant depression TRD without psychosis.

Target Enrollment
Not specified
Study Type
Phase IV interventional
Design
Randomized, quadruple Blind

Detailed Description

Randomized, parallel-group trial comparing two dosing regimens of ketamine (0.5 mg/kg IV): six infusions every other day over 12 days versus two active infusions (days 1 and 7) with four saline placebos.

Primary population: adults 30–65 with treatment-resistant major depressive disorder without psychosis; key exclusions include bipolar disorder, psychosis, imminent suicide risk, unstable medical disease, and recent substance abuse.

Study Protocol

Preparation

sessions

Dosing

6 sessions

Integration

sessions

Study Arms & Interventions

6K

experimental

Six ketamine injections (0.5 mg/kg) every other day over 12 days (days 1,3,5,7,9,11).

Interventions

  • Ketamine0.5 mg/kg
    via IV• every other day• 6 doses total

    Days 1,3,5,7,9,11

2K4P

active comparator

Two active ketamine injections (days 1 and 7) and four placebo (saline) injections (days 3,5,9,11) over 12 days.

Interventions

  • Ketamine0.5 mg/kg
    via IV• two doses (days 1 and 7)• 2 doses total
  • Placebo
    via IV• four saline infusions (days 3,5,9,11)• 4 doses total

    Saline placebo

Participants

Ages
30 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Age 30 to 65
  • Major depressive disorder without psychotic features confirmed by a structured clinical diagnostic interview, SCID.
  • Treatment resistant depression defined using the Antidepressant Treatment History Form (ATHF)
  • HDRS 21 score > 18
  • Female participants of childbearing potential must be using a medically accepted means of contraception (birth control pills, spermicidal barrier)
  • Ability to concur with medication standardization regiment (section as an outpatient
  • Physically healthy (no chronic diseases; normal CBC, BMP, AST, ALT, and UA)
  • Competent to give informed consent to all required tests and examinations and sign a consent document

Exclusion Criteria

  • Exclusion Criteria:
  • Bipolar disorder
  • Psychosis or any other psychotic disorder as defined by DSM-IV criteria
  • Serious or imminent threat for suicide
  • Pregnant or nursing female
  • Presence of serious unstable medical illnesses including hepatic, renal, gastrointestinal, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease, or abnormal laboratory tests (CBC, BMP, AST, ALT, and UA)
  • Uncontrolled hypertension
  • History of CVA
  • Treatment with St. Johns wort, tramadol, phentolamine, naloxone, or anticholinergic medications
  • Alcohol or illicit drug abuse for 6 months (evidence from UDS)
  • Currently involved in a clinical trial or used an experimental medication within the last 30 days
  • Hypersensitivity to ketamine products

Study Details

Locations

St. Mary's Duluth Clinic Health System — Duluth, Minnesota, United States

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