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An EEG Study of Intravenous Ketamine for Major Depression Disorder

NCT05506462 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2022-08-22

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Ketamine Hydrochloride

Patients with a diagnosis of Major Depressive Disorder (MDD) will be enrolled to receive four 50-60 minute infusions of 60mg ketamine hydrochloride

Sponsors & Collaborators

  • Tristar Wellness

    collaborator UNKNOWN

  • Ehave Inc.

    lead INDUSTRY

Principal Investigators

  • Jeffrey D Kamlet, MD · Tristar Wellness

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-31
Primary Completion
2024-01-31
Completion
2024-02-29
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05506462 on ClinicalTrials.gov