An EEG Study of Intravenous Ketamine for Major Depression Disorder

This open-label trial (n=35) will assess the electroencephalographic (EEG) responses before, during, and after low-dose intravenous ketamine infusions over four weeks in patients with major depressive disorder (MDD).

The study aims to characterise changes in EEG readings, including frequencies, waveforms, amplitudes, and patterns, during the ketamine infusion and up to 4 weeks post-treatment. Patients will receive four weekly infusions of 60mg ketamine hydrochloride.

Primary outcomes include changes in EEG readings from baseline, and secondary outcomes focus on physiological parameters like blood pressure, heart rate, and oxygen saturation, along with changes in dissociative experiences. Participants must be between 18 and 70 years old, have a documented diagnosis of MDD, and meet specific screening criteria.

The study is conducted by Tristar Wellness and sponsored by Ehave Inc. Contact details for the study are provided, and enrollment is estimated to occur from January 2023 to January 2024.

Topic Depression
Compound Ketamine
Country Canada
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 January 2023
End date 29 February 2024
Phase Phase IV
Design Open
Type Interventional
Generation First
Participants 35
Sex All
Age 18- 70
Therapy Yes

Trial Details

There are many common pharmacological treatments for major depression disorder (MDD), however the efficacy of these drugs often fails in severe cases. Intravenous (IV) administered ketamine may offer the potential for remission of the symptoms in patients with MDD; however it has not yet been approved by FDA for this purpose. This study will make use of an electroencephalography (EEG) machine to measure the brain's activity and response while the IV ketamine is being delivered. The objective of this study is to characterize the change in EEG response of patients with MDD, during and 4 weeks after a course of IV ketamine infusions.

Trial Number NCT05506462

Sponsors & Collaborators

Ehave
Ehave is playing a main job in the advancement of computerized therapeutics by making an extensible stage whereupon amazing, condition-explicit applications can be planned, fabricated, clinically approved, and sent.

Data attribution

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