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Repeated Neurocognitive Measurements in Depressed Patients

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ClinicalTrials.gov Identifier: NCT04916548
Recruitment Status : Not yet recruiting
First Posted : June 7, 2021
Last Update Posted : August 3, 2021
Sponsor:
Information provided by (Responsible Party):
Rebecca Price, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE May 28, 2021
First Posted Date  ICMJE June 7, 2021
Last Update Posted Date August 3, 2021
Estimated Study Start Date  ICMJE September 2021
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2021)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2021)
  • Montgomery-Asberg Depression Rating Scale [ Time Frame: 24hrs post-intervention ]
    Clinician-rated depression (range: 0-60; higher scores = worse outcome)
  • Montgomery-Asberg Depression Rating Scale [ Time Frame: 5 days post-intervention ]
    Clinician-rated depression (range: 0-60; higher scores = worse outcome)
  • Montgomery-Asberg Depression Rating Scale [ Time Frame: 12 days post-intervention ]
    Clinician-rated depression (range: 0-60; higher scores = worse outcome)
  • Hamilton Depression Rating Scale [ Time Frame: 24hrs post-intervention ]
    Clinician-rated depression (range: 0-52; higher scores = worse outcome)
  • Hamilton Depression Rating Scale [ Time Frame: 5 days post-intervention ]
    Clinician-rated depression (range: 0-52; higher scores = worse outcome)
  • Hamilton Depression Rating Scale [ Time Frame: 12 days post-intervention ]
    Clinician-rated depression (range: 0-52; higher scores = worse outcome)
  • Quick Inventory of Depressive Symptoms [ Time Frame: 24hrs post-intervention ]
    Self-reported depression (range: 0-27; higher scores = worse outcome)
  • Quick Inventory of Depressive Symptoms [ Time Frame: 5 days post-intervention ]
    Self-reported depression (range: 0-27; higher scores = worse outcome)
  • Quick Inventory of Depressive Symptoms [ Time Frame: 12 days post-intervention ]
    Self-reported depression (range: 0-27; higher scores = worse outcome)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Repeated Neurocognitive Measurements in Depressed Patients
Official Title  ICMJE Repeated Neurocognitive Measurements in Depressed Patients
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Depression, Unipolar
Intervention  ICMJE Drug: Intravenous Ketamine
Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)
Study Arms  ICMJE Experimental: Intravenous Ketamine
Open-label ketamine infusion
Intervention: Drug: Intravenous Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 3, 2021)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2024
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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.
  4. Changes made to treatment regimen within 4 weeks of baseline assessment.
  5. Reading level <6th grade as per patient self-report.
  6. Patients who have received ECT in the past 2 months prior to Screening.

Ketamine phase subsample additional exclusion criteria:

  1. Patients currently taking any psychotropic medication.
  2. Lifetime recreational ketamine or PCP use
  3. Current pregnancy or breastfeeding
  4. For ketamine phase entry, patients must be reasonable medical candidates for ketamine infusion, as determined by a physician co-investigator. Serious, unstable medical illnesses including respiratory [obstructive sleep apnea, or history of difficulty with airway management during previous anesthetics], cardiovascular [including ischemic heart disease and uncontrolled hypertension], and neurologic [including history of severe head injury] will be exclusions.
  5. Clinically significant abnormal findings of laboratory parameters [including urine toxicology screen for drugs of abuse], physical examination, or ECG.
  6. 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.
  7. Patients with one or more seizures without a clear and resolved etiology.
  8. Patients starting hormonal treatment (e.g., estrogen) in the 3 months prior to Screening.
  9. Past intolerance or hypersensitivity to ketamine.
  10. 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.
  11. Patients taking any of the following medications: St John's Wort, theophylline, tramadol, metrizamide.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rebecca Price, PhD 4126486445 canlab@pitt.edu
Contact: Crystal Spotts, MEd 4122465764 spottsCR@upmc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04916548
Other Study ID Numbers  ICMJE STUDY21040075
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rebecca Price, University of Pittsburgh
Study Sponsor  ICMJE Rebecca Price
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Pittsburgh
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP