Repeated Neurocognitive Measurements in Depressed Patients

NCT04916548 | Completed Phase 1 Results FDA Drug

• 1 other identifier: STUDY21040075
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression, Unipolar

Outcome Measures

Primary Outcomes (4)

• fMRI Intrinsic Connectivity: Default Mode Network

  functional connectivity normalized correlation values within default mode network (range: -1 to +1; larger value = stronger connectivity, smaller value = weaker connectivity)

  24hrs post-intervention

• fMRI Intrinsic Connectivity: Frontoparietal Control Network

  functional connectivity normalized correlation values within frontoparietal control network (range: -1 to +1; larger value = stronger connectivity, smaller value = weaker connectivity)

  24hrs post-intervention

• fMRI Intrinsic Connectivity: Limbic Network

  functional connectivity normalized correlation values within limbic network (range: -1 to +1; larger value = stronger connectivity, smaller value = weaker connectivity)

  24hrs post-intervention

• fMRI Intrinsic Connectivity: Salience Network

  functional connectivity normalized correlation values within salience ventral attentional network (range: -1 to +1; larger value = stronger connectivity, smaller value = weaker connectivity)

  24hrs post-intervention

Secondary Outcomes (12)

• 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

  24hrs post-intervention

• Montgomery-Asberg Depression Rating Scale

  5 days post-intervention

Other Outcomes (4)

• Dual Probe Video Task

  infusion +24 hours (1 day)

• Pain Rating Via Quantitative Sensory Testing

  1-hour post-infusion

• PROMIS Pain Intensity Score

  1-hour post-infusion

Study Arms (1)

Intravenous Ketamine

EXPERIMENTAL

Open-label ketamine infusion

Drug: Intravenous Ketamine

Interventions

Intravenous Ketamine DRUG

Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)

Intravenous Ketamine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• All participants:
• Presence of lifetime bipolar, psychotic, or autism spectrum; current problematic substance use (e.g., ongoing moderate-to-severe substance use disorder);
• 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.
• Patients currently taking any psychotropic medication.
• Lifetime recreational ketamine or PCP use
• Current pregnancy or breastfeeding
• Clinically significant abnormal findings of laboratory parameters \[including urine toxicology screen for drugs of abuse\], physical examination, or ECG.
• Uncontrolled or poorly controlled hypertension, as determined by a physician co-investigator's review of vitals collected during screening and any other relevant medical history/records.
• Patients with one or more seizures without a clear and resolved etiology.
• Patients starting hormonal treatment (e.g., estrogen) in the 3 months prior to Screening.
• Past intolerance or hypersensitivity to ketamine.
• Patients taking medications with known activity at the NMDA or AMPA glutamate receptor \[e.g., riluzole, amantadine, lamotrigine, memantine, topiramate, dextromethorphan, Dcycloserine\], or the mu-opioid receptor.
• Patients taking any of the following medications: St John's Wort, theophylline, tramadol, metrizamide.

Sponsors & Collaborators

• Rebecca Price: lead

Study Sites (1)

Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Depressive Disorder

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Rebecca Price
• Organization: University of Pittsburgh

pricerb@upmc.edu

412-383-2150

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Psychiatry and Psychology

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: June 7, 2021
• Study Start: September 16, 2021
• Primary Completion: July 15, 2023
• Study Completion: August 15, 2023
• Last Updated: August 20, 2024
• Results First Posted: August 20, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)