None listed
Conditions
Brief 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.
Interventions
Ketamine. During 4-week RCT and 4-week open label extension phase with 1 month break between the two phases, A follow up is scheduled 1 month after the end of RCT where participants will be further screened for eligibility (as per RCT criteria) to enter the open label phase with the only difference being that participants are not blinded to the drug administered.
Ketamine (concentration 100mg/mL) will be administered via subcutaneous injection twice weekly for 4 weeks in each phase. Starting do
Ketamine. During 4-week RCT and 4-week open label extension phase with 1 month break between the two phases, A follow up is scheduled 1 month after the end of RCT where participants will be further screened for eligibility (as per RCT criteria) to enter the open label phase with the only difference being that participants are not blinded to the drug administered. Ketamine (concentration 100mg/mL) will be administered via subcutaneous injection twice weekly for 4 weeks in each phase. Starting dose will range between 0.22-0.53 mL depending on body weight. 41-45 kg 0.22 mL 46-50 kg 0.24 mL 51-55 kg 0.27 mL 56-60 kg 0.29 mL 61-70 kg 0.33 mL 71-80 kg 0.38 mL 81-90 kg 0.43 mL 91-100 kg 0.48 mL >100 kg 0.53 mL Adherence will be self apparent as study personnel will administer the intervention in person via injection, The dose may be increased depending on progress and tolerability of side effects. Upper limit of intervention drug depends on body weight but the maximum is 0.91 mL.
Sponsors
University of New South Wales
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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
Outcome results
None listed