Repeated Neurocognitive Measurements in Depressed Patients

Jay Fournier1 site in 1 country20 target enrollmentMay 1, 2025

ConditionsDepression, Unipolar

InterventionsIntravenous Ketamine

DrugsIntravenous Ketamine

Overview

Phase: Phase 1
Intervention: Intravenous Ketamine
Conditions: Depression, Unipolar
Sponsor: Jay Fournier
Enrollment: 20
Locations: 1
Primary Endpoint: fMRI resting state connectivity
Status: Withdrawn
Last Updated: 2 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

In this project, we will A) track the functioning of a collection of potential neurobiological targets for depression over time, B) examine how fluctuations in the functioning of those targets relates to real-world functioning, and C) in a subset of the sample, determine how the functioning in those targets is altered by a single dose of ketamine.

Registry

clinicaltrials.gov

Start Date

May 1, 2025

End Date

April 1, 2029

Last Updated

2 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Jay Fournier

Responsible Party

Sponsor Investigator

Principal Investigator

Jay Fournier

Associate Professor, Department of Psychiatry & Behavioral Health

Ohio State University

Eligibility Criteria

Inclusion Criteria

•All participants will:
•be between the ages of 18 and 60 years,
•score ≥ 14 on the Hamilton Depression Rating Scale (Ham-D)
•possess a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document

Exclusion Criteria

•All participants:
•Presence of lifetime bipolar, psychotic, or autism spectrum; current problematic substance use (e.g., ongoing moderate-to-severe substance use disorder);
•Failure to meet standard MRI inclusion criteria: those who have cardiac pacemakers, neural pacemakers, cochlear implants, metal braces, or other non-MRI-compatible metal objects in their body. History of significant injury or surgery to the brain or spinal cord that would impair interpretation of results.
•Acute suicidality or other psychiatric crises requiring treatment escalation. We will use the Columbia Suicide Severity Rating Scale (CSSRS) as both an initial exclusion criteria (CSSRS "Baseline/Screening" Version for past 1month period) and as grounds for rescue/removal (CSSRS "Since Last Visit" form). The CSSRS will be administered using a paper form by an experienced and thoroughly trained clinical assessor on the study team. Subjects with CSSRS suicide ideation scores scored "yes" on items 4 (active suicidal ideation with some intent to act) and/or 5 (active suicidal ideation with specific plan and intent) will be excluded from the study, and if enrolled, will be exited from the study and referred immediately to the nearest emergency mental health facility for additional thorough assessment and appropriate treatment referral.
•Changes made to treatment regimen within 4 weeks of baseline assessment.
•Reading level \<6th grade as per patient self-report.
•Patients who have received ECT in the past 2 months prior to Screening.
•Ketamine phase subsample additional exclusion criteria:
•Patients currently taking any psychotropic medication.
•Lifetime recreational ketamine or PCP use

Arms & Interventions

Intravenous Ketamine

Open-label ketamine infusion

Intervention: Intravenous Ketamine

Outcomes

Primary Outcomes

fMRI resting state connectivity

Time Frame: 24hrs post-intervention

directed connectivity beta weights between default mode, frontoparietal, limbic/affective, and salience networks (larger beta weight = stronger connectivity)