Ketamine Clinical Trials
A randomised controlled feasibility study of ketamine-assisted therapy: Does fractal priming improve treatment response in treatment-resistant depression?
To see complete record on anzctr.org.au, please visit this link
Id: ACTRN12621000562875
Organisation Name: University of Auckland
Overal Status: Not yet recruiting
Start Date: 12/07/2021
Brief Summary: In this study, we will recruit from an adult population with treatment-resistant depression throughout the Auckland region. The study hypothesis is that participants viewing certain images prior to treatment will have an improved outcome. The study is also designed to explore the practical aspects of designing a larger study in the future. After appropriate screening and informed consent, each participant will be treated with intramuscular ketamine in combination with a brief psychotherapeutic intervention. The participants will be randomised to receive either an enhanced setting in the form of time variable fractal viewing or treatment as usual. The sample size will be thirty participants. The primary outcome measure will be the clinical benefit as based on percentage change in the Montgomery-Asberg Depression Rating Scale (MADRS) at 4hr, 1 day, 7 day and 28 days post-treatment. The post-treatment assessment will be blinded between the enhanced group and the control group. This is a feasibility study to explore the testing study procedures, validity of tools, and recruitment rate in order to design a larger study involving use of ketamine in combination with psychotherapy for the treatment-resistant population.
Countries:
- New Zealand
- Auckland Region
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