This non-randomised trial (n=25) investigates the effects of ketamine on anxiety ratings in patients with anxiety disorders, specifically Generalized Anxiety Disorder (GAD) or Social Phobia (SP).
Registered on ANZCTR, the trial, conducted in New Zealand by the University of Otago, began enrolment on November 10, 2015, and completed on October 11, 2017.
Led by Prof Paul Glue, the study comprises three phases: an open-label ascending single dosing of ketamine (0.25, 0.5, 1 mg/kg subcutaneously) in patients with GAD or SP; a double-blind ascending single dosing of ketamine (with midazolam 0.01mg/kg as active control); and a maintenance phase involving 1-2x weekly ketamine dosing for up to 3 months.
The primary outcome is the change in anxiety rating scales (HAM-A for GAD; SSAI plus FQ items for SP) at various timepoints, with safety, tolerability, and additional measurements including blood samples and depression ratings.
The study aims to assess if ketamine produces rapid improvements in anxiety symptoms, similar to its effects on depression, OCD, and PTSD. Results have been published in peer-reviewed journals, including “J Psychopharmacol” in 2017 and 2018, and “Journal of Psychopharmacology” in 2020.
Trial Details
The glutamate antagonist ketamine has rapid onset antidepressant effects in patients with treatment-resistant depression. Patients with OCD and PTSD have had similarly rapid improvement in symptoms when administered ketamine. This study will assess if similar improvements occur in patients with GAD and SP.NCT Number ACTRN12615000617561
Sponsors & Collaborators
University of OtagoThe University of Otago (specifically the Dunedin School of Medicine) is associated with psychedelic research but doesn't yet have a full profile.