Depression, Unipolar
Conditions
Keywords
Depressive Disorder, Mood Disorders, Mental Disorders, Ketamine, Analgesics, Sensory System Agents, Peripheral Nervous System Agents, Physiological Effects of Drugs, Anesthetics, Dissociative, Anesthetics, Intravenous, Anesthetics, General, Anesthetics, Central Nervous System Depressants, Excitatory Amino Acid Antagonists, Excitatory Amino Acid Agents, Neurotransmitter Agents, Molecular Mechanisms of Pharmacological Action
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.
Interventions
Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)
Sponsors
Jay Fournier
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
All participants will: 1. be between the ages of 18 and 60 years, 2. score ≥ 14 on the Hamilton Depression Rating Scale (Ham-D) 3. 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: 1. Presence of lifetime bipolar, psychotic, or autism spectrum; current problematic substance use (e.g., ongoing moderate-to-severe substance use disorder); 2. 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. 3. Acute suicidality or other psychiatric crises requiring treatment escalation. We will use the Columbia Suicide Severity Rating Scale (CSSRS) as both an initial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| fMRI resting state connectivity | 24hrs post-intervention | directed connectivity beta weights between default mode, frontoparietal, limbic/affective, and salience networks (larger beta weight = stronger connectivity) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Montgomery-Asberg Depression Rating Scale | 24hrs post-intervention | Clinician-rated depression (range: 0-60; higher scores = worse outcome) |
| Hamilton Depression Rating Scale | 24hrs post-intervention | Clinician-rated depression (range: 0-52; higher scores = worse outcome) |
| Quick Inventory of Depressive Symptoms | 24hrs post-intervention | Self-reported depression (range: 0-27; higher scores = worse outcome) |
Countries
United States
Outcome results
None listed