Randomised, controlled, parallel-group, pilot clinical trial of ketamine vs. midazolam as adjunctive therapy for depression. The main purpose of the pilot study is to assess trial processes to help inform a future definitive trial.
Topic Depression
Compound Ketamine
Country Ireland
Visit trial
Status
Completed
Results Published
Start date
17 September 2017
End date
21 September 2018
Chance of happening
100%
Phase
Phase I
Design
Blinded
Type
Interventional
Generation
First
Participants
25
Sex
All
Age
18- 99
Therapy
No
Trial Details
Pragmatic, randomised, controlled, parallel-group, pilot trial. Trial participants will be patients admitted to St Patrick's University Hospital for treatment of a depressive episode. The investigators aim to recruit up to 20 participants who will be eligible for this study and randomly allocate 10 patients to each group. The participants will undergo usual inpatient care as prescribed by their treating team for the index acute depressive episode. Both participants and assessors will be blind to treatment allocation. Consented participants will be randomly allocated in a 1:1 ratio to a four week course of either once-weekly ketamine or midazolam infusions. Block randomisation will be independently performed. Physical, psychotomimetic and cognitive outcomes will be monitored before, during and after infusions. Blood samples will be taken at four time-points in the first infusion session and before the final infusion for neuroplasticity biomarker studies. Both groups will continue treatment as usual. Participates will also be followed up over a three month period.NCT Number NCT03256162
Sponsors & Collaborators
St Patrick's HospitalSt Patrick's University Hospital is a psychiatric hospital affiliated with Trinity College Dublin.
Papers
Ketamine as an adjunctive therapy for major depression - a randomised controlled pragmatic pilot trial (Karma-Dep Trial)This trial (n=25) compared the effects of ketamine infusion (n=13, 35mg/70kg) to midazolam (n=12, 3.1mg/70kg) administered once-weekly to people experiencing a depressive episode. There were no major differences between groups as measured using the Hamilton Rating Scale for Depression (HRSD-24).