Management of the australianclinicaltrials.gov.au website has been transferred from NHMRC to the Commonwealth Department of Health. Disruption to site users as a consequence of this change should be minimal. Users should note that email notifications coming from the website will come from email@example.com from Friday the 8th of April 2022. Any user experiencing difficulty as a result of this change should direct enquiries to firstname.lastname@example.org for assistance.
Broad Health Condition Mental Health
Specific Health ConditionDepression
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
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
Sponsor Primary Sponsor Type: University
Primary Sponsor Name: University of New South Wales
Primary Sponsor Address: UNSW Sydney, NSW 2052, Australia
Primary Sponsor Country: Australia
Contact person for information and recruitmentDr
Black Dog Institute, Hospital Road, Randwick NSW Australia 2031
+61 2 9382 2987