Repeated Neurocognitive Measurements in Depressed Patients
Overview
- Phase
- Phase 1
- Intervention
- Intravenous Ketamine
- Conditions
- Depression, Unipolar
- Sponsor
- Rebecca Price
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- fMRI Intrinsic Connectivity: Limbic Network
- Status
- Completed
- Last Updated
- last year
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.
Investigators
Rebecca Price
Associate Professor of Psychiatry and Psychology
University of Pittsburgh
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 Intrinsic Connectivity: Limbic Network
Time Frame: 24hrs post-intervention
functional connectivity normalized correlation values within limbic network (range: -1 to +1; larger value = stronger connectivity, smaller value = weaker connectivity)
fMRI Intrinsic Connectivity: Frontoparietal Control Network
Time Frame: 24hrs post-intervention
functional connectivity normalized correlation values within frontoparietal control network (range: -1 to +1; larger value = stronger connectivity, smaller value = weaker connectivity)
fMRI Intrinsic Connectivity: Salience Network
Time Frame: 24hrs post-intervention
functional connectivity normalized correlation values within salience ventral attentional network (range: -1 to +1; larger value = stronger connectivity, smaller value = weaker connectivity)
fMRI Intrinsic Connectivity: Default Mode Network
Time Frame: 24hrs post-intervention
functional connectivity normalized correlation values within default mode network (range: -1 to +1; larger value = stronger connectivity, smaller value = weaker connectivity)
Secondary Outcomes
- Quick Inventory of Depressive Symptoms(12 days post-intervention)
- fMRI Intrinsic Connectivity: Dorsal Attention Network(24hrs post-intervention)
- fMRI Intrinsic Connectivity: Somatosensory Motor Network(24hrs post-intervention)
- fMRI Intrinsic Connectivity: Visual Network(24hrs post-intervention)
- Montgomery-Asberg Depression Rating Scale(12 days post-intervention)
- Hamilton Depression Rating Scale (Modified Score)(12 days post-intervention)