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Pharmacogenetics Associated With IV Ketamine

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ClinicalTrials.gov Identifier: NCT04695405
Recruitment Status : Not yet recruiting
First Posted : January 5, 2021
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
Brain and Cognition Discovery Foundation

Tracking Information
First Submitted Date December 28, 2020
First Posted Date January 5, 2021
Last Update Posted Date January 5, 2021
Estimated Study Start Date January 2021
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 3, 2021)
  • Genetic Biomarkers [ Time Frame: 1 month ]
    Genetic markers associated with metabolism of IV ketamine will be assessed
  • Quick Inventory of Depressive Symptomatology Self Report 16-Item [ Time Frame: Over 1-2 weeks ]
    The QIDS-SR16 is a self-report assessment used to evaluate depression severity in patients with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, diagnosis of Major Depressive Episode. In total, there are 16 individual questions evaluating 9 DSM domains. The highest score is 27, indicating severe depression, while the lowest score is 0, which would suggest a complete absence of depressive symptoms.
  • Generalized Anxiety Disorder 7-item [ Time Frame: Over 1-2 weeks ]
    The GAD-7 is a 7 item self-report assessment used to evaluate symptoms of anxiety. The scale ranges from 0 (not at all) to 3 (nearly every day). To total score ranges from 0 suggesting a lack anxiety symptoms to 21, indicating severe anxiety.
  • Snaith-Hamilton Pleasure Scale [ Time Frame: Over 1-2 weeks ]
    The SHAPS assessment is a 14 item self report tool used to measure anhedonia. Each item can be have a response of 1 (Definitely agree), 2(Agree), 3(Disagree), and 4(definitely disagree). The total score ranges from 14 to 56, in which higher scores on the assessment indicate higher levels of anhedonia.
  • Sheehan Disability Scale [ Time Frame: Over 4 initial infusions ]
    The SDS contains 3 items, each ranging between zero to ten. The SDS is a self-reported assessment of disability within the context of depression. The total score ranges from 0, indicating no impairment, to 30, indicating severe impairment.
  • Clinician Administered Dissociative States Scale [ Time Frame: Over 1-2 weeks ]
    The CADSS is a 23-item assessment administered by a clinician in order to evaluate dissociative symptoms. Each item is evaluated on a scale from 0, suggesting no dissociative symptom, to 4, suggesting extreme dissociation. In total, patients can score between 0 to 92, indicating extreme dissociation.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: January 3, 2021)
  • Work Productivity and Activity Impairment Questionnaire (WPAI) [ Time Frame: 1 month ]
    WPAI is a questionnaire used to evaluate lost productivity due to depression. scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.
  • Mystical Experience Questionnaire (MEQ) [ Time Frame: 1 month ]
    Mystical Experience Questionnaire (MEQ) is a self-report measure that has been used to assess the effects of hallucinogens in laboratory studies. Some studies suggest that mysticism may be associated with a response to ketamine. The MEQ is a 30 item questionnaire, with each item ranging from 0 to 5. A higher score denotes a strong mystical experience.
  • Childhood Trauma Questionnaire (CTQ) [ Time Frame: 1 month ]
    The CTQ assesses five types of childhood trauma: 1)Emotional neglect 2) physical abuse 3) emotional abuse 4)physical neglect 5) sexual abuse. Each item being rated in 5 answer choice from 1 to 5 (never, rarely, sometimes, often or very often)
  • UCLA Loneliness Scale (UCLA) [ Time Frame: 1 month ]
    20 item Self report scale measuring loneliness. Scales range from 0 to 60 with higher scores indicating a higher level of loneliness.
  • Diet Screener Questionnaire [ Time Frame: 1 month ]
    Captures data regarding an individuals dietary habits over the past month
  • Quality of Life Questionnaire (EQ-3D-5L) [ Time Frame: 1 month ]
    EQ-5D-5L measures health outcome self-completed by respondents. It consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ-VAS). The descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each has 5 levels (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). The responses are used to generate Health Status Index (HSI). HSI range is -0.148 to 0.949, is anchored at 0 (dead) and 1 (full health).
  • Perceived Health Questionnaire (PHQ) [ Time Frame: 1 month ]
    PHQ-9 is 9-item, self-reported scale assessing 9 symptom domains of Diagnostic and Statistical Manual of Mental Disorders, Major Depressive Disorder criteria. Each item is rated on 4-point scale (0 = Not at all, 1 = Several Days, 2 = More than half days, 3 = Nearly every day). The scores are summed for a total score ranging from 0-27. Higher score indicates greater severity of depression. Severity of PHQ-9 categorized as follows: None-minimal (0-4), Mild (5-9), Moderate (10-14), Moderately Severe (15-19), Severe (20-27). The recall period is 2 weeks.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pharmacogenetics Associated With IV Ketamine
Official Title Genetic Markers Associated With Response to Intravenous Ketamine
Brief Summary The Canadian Rapid Treatment Center of Excellence (CRTCE) is a healthcare facility principally focused on providing best practices of intravenous ketamine treatment to adult patients suffering from treatment resistant depression. Patients who have received IV ketamine at the clinic are eligible to participate in this study where genetic biomarkers are correlated with response to IV ketamine.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Patients will provide two saliva samples containing genetic information.
Sampling Method Non-Probability Sample
Study Population All participants will have received IV ketamine previously for treatment resistant depression, as defined by the DSM-5
Condition Treatment Resistant Depression
Intervention Genetic: Saliva Genetic Samples
Patients will provide two saliva swabs containing genetic materials.
Study Groups/Cohorts Treatment-Resistant Depression
Patients, who previously received intravenous ketamine, will be asked to provide genetic samples in order to assess relationships between response and genetic markers.
Intervention: Genetic: Saliva Genetic Samples
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 Not yet recruiting
Estimated Enrollment
 (submitted: January 3, 2021)
150
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2021
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Must have received IV ketamine previously to treat Treatment-Resistant Depression
  2. Between the ages of 18-65 years old.
  3. Clinical diagnosis of MDD
  4. Individuals may have had comorbid psychiatric conditions (e.g., anxiety), but the comorbid psychiatric condition cannot be the primary clinical concern.
  5. Ability to provide informed consent

Exclusion Criteria:

  1. Individuals who meet DSM 5 criteria for a substance use and/or alcohol use disorder in the past 3 months.
  2. Individuals who are currently experiencing psychotic symptoms as part of an MDE (mood congruent/mood incongruent).
  3. Individuals who are unable to consent to the procedure.
  4. Individuals who are unable to adhere to the protocol in its totality
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Nelson Rodrigues, MSc 416-430-9619 nelson.rodrigues@crtce.com
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT04695405
Other Study ID Numbers Ket-PGx
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared due to confidentiality. Only aggregate data will be published or made available.
Responsible Party Brain and Cognition Discovery Foundation
Study Sponsor Brain and Cognition Discovery Foundation
Collaborators Not Provided
Investigators
Principal Investigator: Joshua D Rosenblat, MD, MSc Canadian Rapid Treatment Center of Excellence
PRS Account Brain and Cognition Discovery Foundation
Verification Date January 2021