Australian Clinical Trials

Broad Health Condition Mental Health

Specific Health ConditionDepression

Trial FocusTreatment

Recruitment Details

Recruitment status
Completed

Recruitment State
NSW

Hospital

Phase of TrialPhase 3

Has the study received ethics approval?Approved

Trial summary

The aim of this study is to determine if a course of ketamine is an effective therapy for depression. The study will also determine if repeated ketamine doses: 1) are safe, tolerable and feasible in outpatient settings; 2) provide sustained antidepressant benefits; 3) improve anxiety, suicidal ideation and health related quality of life; 4) are a cost effective treatment. 200 participants will be recruited across 6 sites in Australia (Black Dog Institute, Sydney; Royal Prince Alfred Hospital, Sydney; Monash Alfred Psychiatry Research Centre, Melbourne; South Eastern Private Hospital, Noble Park; Royal Adelaide Hospital, Adelaide; Gold Coast University Hospital, Gold Coast) and 1 in New Zealand (Dunedin, Otago). The study is a randomised controlled trial. Participants will be randomised to receive repeated doses of ketamine or a comparator treatment. For all participants, a follow-up assessment after finishing the randomised controlled phase will assess eligibility for an open label extension phase. All participants will be followed up after exiting the trial to assess treatment effects.

Key inclusion criteria

Criteria assessed by the research team include:
-Major Depressive Disorder (MDD) for at least 3 months.
-An inadequate response to at least 2 adequate antidepressants courses. Stable dose of antidepressant medications at least 4 weeks prior to trial entry.
-Montgomery Asberg Depression Rating Scale (MADRS) score of at least 20.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate? No

Key exclusion criteria

Criteria assessed by the research team to determine suitability include:
- Psychotic disorder.
- Bipolar disorder.
-Medical and neurologic conditions.
-Psychiatric disorders other than MDD.
-Planned major changes to psychotropic medication.
-Planned or probable use of ECT.
-Risk of suicide. 
-Substance use, abuse, dependence.
-Recent or planned ketamine treatment.
-Medical conditions in which use of ketamine or sedating medications may pose a significant health risk.  
-Women of childbearing potential not taking reliable contraception.
- inability to complete the trial