Ketamine Trial for the Treatment of Depression

• Status: Unknown status
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of New South Wales
• Collaborator: University of Sydney
• Treatments: Ketamine

Criteria

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