Effect of Ketamine on Neurological Activity as Measured by Electroencephalogram (EEG)

NCT05095792 | Terminated

• 1 other identifier: EBIQ-101
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study will allow data to be collected to demonstrate changes in brain activity following administration of standard of care (SOC) Ketamine. By comparing genetic markers across participants, data on impact of genetic markers and response to Ketamine will also be analysed. This data will contribute to the design of future studies utilizing Ketamine for various psychiatric disorders. This study will focus on treatment-resistant Major Depressive Disorder (MDD).

Conditions

Treatment-resistant Depression

Outcome Measures

Primary Outcomes (1)

• Inter and intra patient variability in neurological activity.

  Observation of the the inter and intra patient variability in neurological activity.

  Up to 74 days

Secondary Outcomes (4)

• Genetic markers on neurological phenotypes

  Baseline

• CADSS-6 correlation with neurological phenotypes

  Up to 67 days

• QIDS SR-16 correlation with neurological phenotypes

  Up to 67 days

• PMQ-SF correlation with neurological phenotypes

  Up to 67 days

Interventions

Observational - no intervention OTHER

This is an observational study with no intervention.

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Male or female participants with treatment-resistant Major Depressive Disorder aged 21-60 interested in receiving intra-muscular injections of ketamine over 10 sessions in the clinic and willing to wear an electroencephalogram (EEG) headset to measure their brain wave patterns.

You may qualify if:

• Primary Diagnostic and Statistical Manuel of Mental Disorders 5 (DSM-V) diagnosis of treatment-resistant Major Depressive Disorder (may have secondary diagnoses of general anxiety, substance disorder)
• Non-responders to at least 2 previous anti-depressant medications prescribed by a physician in the past five years
• Score of ≥20 on Montgomery-Asberg Depression Rating Scale (MADRS) (i.e., moderate to severe depression)
• All genders aged 21 to 60 years of age
• Prescribed Ketamine or currently being treated with Ketamine for treatment-resistant Major Depressive Disorder
• Willing to wear an Electroencephalogram (EEG) headset and an eye mask
• Willing to listen to ambient sound
• Willing to have a genetic cheek swab

You may not qualify if:

• Pregnancy
• Traumatic Brain Injury within past 3 months
• Body weight \< 50 kg or \> 120 kg
• Coronary heart disease
• Uncontrolled hypertension as defined in the American College of Cardiology/American Heart Association (ACC/AHA) Hypertension Guidelines
• Previous contact with Ketamine (therapeutically or recreationally) outside of treatment at the study site
• Primary psychotic disorder (e.g., schizophrenia, schizoaffective disorder)
• Bipolar disorder with current manic, hypomanic or mixed state
• Post-traumatic stress disorder
• Obsessive-compulsive disorder
• Primary substance-use disorder
• Alcohol consumption 24 hours prior and 48 hours subsequent to treatment
• Currently using any of the following medications:
• Benzodiazepines for 6 hours prior to treatment and 2 hours after treatment
• Lamotrigine for 6 hours prior to treatment

Sponsors & Collaborators

• Entheon Biomedical Corp.: lead

Study Sites (1)

Heading Health

Austin, Texas, 78746, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Steven Levine, MD

  Heading Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: October 27, 2021
• Study Start: November 9, 2021
• Primary Completion: October 21, 2022
• Study Completion: October 21, 2022
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)