Integrating Ketamine Effects on Neuronal Molecular Signatures and the Brain Functional and Structural Connectome

NCT06698848 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: 2024P001580
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Subanesthetic dose of intravenous ketamine (KET) has been found to be highly effective in rapid treatment depression and associated suicidality but its exact mechanism of remains uncertain. This study will use a novel approach to elucidate KET's effects on the molecular/ gene expression pathways in living neurons obtained from the olfactory epithelium and correlate the changes to rapid improvement in depression via changes in the brain connectome. The study will identify the molecular targets and pathways involved in KET'S mechanism of rapid clinical action and pave the way for development of novel, more efficacious, and safer therapeutic agents.

Conditions

Depression; Suicide

Outcome Measures

Primary Outcomes (1)

• Montgomery Asberg Rating Scale (MADRS)

  From enrollment to end of 1 week treatment

Study Arms (1)

Intravenous Ketamine

EXPERIMENTAL

Intravenous ketamine will be given at a dose of 0.5 mg/kg over 40 minutes with a maximum dose of 60 mg.

Drug: ketamin

Interventions

ketamin DRUG

Participants in this study will have been diagnosed with major depressive episode (MDE) and have not received any psychiatric treatment for at least 2 weeks (5 weeks if on fluoxetine).Patients will receive intravenous ketamine as the only study drug treatment for the 2 weeks of the study. Magnetic Resonance Imaging (MRI) will be used to measure effects of ketamine on brain structure, function and chemistry, in addition to a soft-nasal brushing procedure to obtain olfactory sensory neurons which will provide the ability to profile in vivo how neurons may react to KET treatment in depressed patients.

Intravenous Ketamine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• \. Meeting DSM-5 criteria for (hypo)mania, bipolar disorder, schizophrenia, schizophreniform disorder, schizoaffective disorder, intellectual disability, or pervasive developmental disorder; 2. History of receiving electroconvulsive therapy in the past 1 year (due to possible effects on brain morphology); 3. Meeting DSM-5 criteria for moderate or severe substance/alcohol use within the past 6 months excluding caffeine or nicotine. The criteria will be evaluated by interview and urinary toxicology screening. The typical weekly use of caffeine, nicotine and alcohol will be recorded; 4. No serious medical or neurological illness, including previously known HIV positive status (due to possible CNS involvement) as assessed by history, physical examination and laboratory examination including EKG, CBC and blood chemistry; 5. Current pregnancy or breast feeding; 6. Metallic implants or contraindication to MRI.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hosipital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Depression; Suicide

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Self-Injurious Behavior

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: BWPO Physician

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 21, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 30, 2030
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

US (1)