Action of Ketamine in Treatment-Resistant... — Clinical Trial Details

Participants

Ages

18 – 65

Sexes

Male & Female

BMI

Psychosis History

Only participants from the Ottawa area will be considered
Provision of written informed consent before initiation of any study-related procedures.
Documented primary Axis I clinical diagnosis meeting criteria from the DSM-IV for MDD, as confirmed by the MINI.
Failure to respond adequately to at least two antidepressant medication trials and two augmentation strategies (one augmentation may include venlafaxine 225 mg/day or duloxetine 120 mg/day, or a 12-week CBT or interpersonal therapy).
MADRS total score ≥ 25 at screening and randomization, with no more than 20% improvement between these two visits.
Female subjects of childbearing potential must have a negative urine pregnancy test at enrolment and be willing to use a reliable method of birth control during the study.
Abstain from consuming grapefruit juice on the day of the infusions.
Be able to understand and comply with study requirements, as judged by the investigator(s).

Subjects with a DSM-IV Axis II disorder that majorly impacts current psychiatric status.
Depression secondary to stroke, cancer or other severe medical illnesses.
Prior or current substance or alcohol abuse or dependence (except caffeine or nicotine).
A positive drug screen.
Unwilling to maintain current antidepressant regimen.
Unwilling or unable to withhold benzodiazepines or narcotics for required washout periods prior to infusions.
Pregnant or lactating, or of childbearing potential and not willing to use approved contraception during the study.
Evidence of clinically relevant disease (e.g., renal/hepatic impairment, significant coronary artery disease, cerebrovascular disease, viral hepatitis B/C, AIDS).
Unstable clinical findings that would be negatively affected by study medication (e.g., uncontrolled diabetes, hypertension, unstable angina).
AST or ALT ≥3× upper normal limit at screening.
Uncorrected thyroid disease unless on a stable replacement dose for ≥30 days.
Clinically significant laboratory or ECG abnormalities.
History of seizure disorder (except febrile convulsions).
Subjects judged to require psychotherapy (other than supportive) during the study unless psychotherapy has been ongoing for ≥2 months prior to Visit 2.
Known intolerance or hypersensitivity to ketamine or midazolam.
Any other condition that would adversely affect participation, per investigator opinion.

Action of Ketamine in Treatment-Resistant Depression