An EEG Study of Intravenous Ketamine for Major Depression Disorder

Major Depressive Disorder Clinical Trial

Official title: An Open Label Study of Electroencephalographic Responses Pre, During and Post, a Low Dose, Weekly Intravenous Ketamine Infusion for 4 Weeks, in a Study Population With Major Depression Disorder

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial Description

This study will enroll 35 patients with major depressive disorder. Candidates for participation in the study will typically be either referred to the clinic through their healthcare provider or will have sought out participation on their own accord based on advertising. Subjects will be screened for eligibility and suitable patients will be invited to attend a screening visit in the clinic and complete informed consent.

Upon determining eligibility, subjects will have their first treatment session booked within 42 days of screening (Baseline, visit 0). Three subsequent weekly (±3 days) ketamine therapy treatment sessions will occur on days 7, 14 and 21, for a total of four ketamine infusions over four weeks. All patients will return for a follow-up visit at 4-weeks post final treatment visit, day 49. ;

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

• NCT number: NCT05506462
• Study type: Interventional
• Source: Ehave Inc.
• Contact: Jeffrey D Kamlet, MD
• Phone: 305 604 9595
• Email: jeffrey@tristarwell.com
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: January 2023
• Completion date: February 2024