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Repeated Neurocognitive Measurements in Depressed Patients

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ClinicalTrials.gov Identifier: NCT04916548
Recruitment Status : Recruiting
First Posted : June 7, 2021
Last Update Posted : September 23, 2021
Sponsor:
Information provided by (Responsible Party):
Rebecca Price, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Depression, Unipolar Drug: Intravenous Ketamine Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Repeated Neurocognitive Measurements in Depressed Patients
Actual Study Start Date : September 16, 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: Intravenous Ketamine
Open-label ketamine infusion
Drug: Intravenous Ketamine
Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Montgomery-Asberg Depression Rating Scale [ Time Frame: 24hrs post-intervention ]
    Clinician-rated depression (range: 0-60; higher scores = worse outcome)

  2. Montgomery-Asberg Depression Rating Scale [ Time Frame: 5 days post-intervention ]
    Clinician-rated depression (range: 0-60; higher scores = worse outcome)

  3. Montgomery-Asberg Depression Rating Scale [ Time Frame: 12 days post-intervention ]
    Clinician-rated depression (range: 0-60; higher scores = worse outcome)

  4. Hamilton Depression Rating Scale [ Time Frame: 24hrs post-intervention ]
    Clinician-rated depression (range: 0-52; higher scores = worse outcome)

  5. Hamilton Depression Rating Scale [ Time Frame: 5 days post-intervention ]
    Clinician-rated depression (range: 0-52; higher scores = worse outcome)

  6. Hamilton Depression Rating Scale [ Time Frame: 12 days post-intervention ]
    Clinician-rated depression (range: 0-52; higher scores = worse outcome)

  7. Quick Inventory of Depressive Symptoms [ Time Frame: 24hrs post-intervention ]
    Self-reported depression (range: 0-27; higher scores = worse outcome)

  8. Quick Inventory of Depressive Symptoms [ Time Frame: 5 days post-intervention ]
    Self-reported depression (range: 0-27; higher scores = worse outcome)

  9. Quick Inventory of Depressive Symptoms [ Time Frame: 12 days post-intervention ]
    Self-reported depression (range: 0-27; higher scores = worse outcome)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04916548


Contacts
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Contact: Rebecca Price, PhD 4126486445 canlab@pitt.edu
Contact: Crystal Spotts, MEd 4122465764 spottsCR@upmc.edu

Locations
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United States, Pennsylvania
Western Psychiatric Institute and Clinic Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Rebecca Price, PhD    412-648-6445    canlab@pitt.edu   
Sponsors and Collaborators
Rebecca Price
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Responsible Party: Rebecca Price, Associate Professor of Psychiatry and Psychology, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT04916548    
Other Study ID Numbers: STUDY21040075
First Posted: June 7, 2021    Key Record Dates
Last Update Posted: September 23, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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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