Ketamine Trial for the Treatment of Depression

Ketamine Therapy Among Patients With Treatment-resistant Depression: a Randomised, Double-blind, Placebo-controlled Trial: Pilot Phase

This study is a Randomized Controlled Trial, investigating the safety and efficacy of administration of ketamine as a potential treatment for depression.

Individuals will be eligible for enrolment on the basis of:

• major depressive disorder for at least three months duration
• an inadequate response to at least 2 adequate antidepressants
• MADRS ≥ 20

Patients will be excluded on the basis of:

• History of psychosis
• History of bipolar disorder
• Any unstable medical or neurologic condition
• Any Axis I disorder other than MDD judged to be primary presenting problem
• Planned major changes to psychotropic medication
• Significant risk of suicide
• Planned or probable use of ECT
• Age under 16 years, or 16-17 years without parental consent
• Substance abuse or dependence in previous 6 months
• Any history of abuse of ketamine or phencyclidine
• Contraindication to the use of ketamine
• Planned use of ketamine
• Women of childbearing potential not taking reliable contraception
• Likely non-compliance with trial treatment
• Other condition judged by the treating clinician as likely to impact on the ability of the participant to complete the trial