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OpenTrials
Completed

NCT Number: NCT04695405

Pharmacogenetics Associated With IV Ketamine

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Canadian Rapid Treatment Centre of Excellence

Mississauga, Ontario, L5C 4E7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Individuals who meet DSM 5 criteria for a substance use and/or alcohol use disorder in the past 3 months.
  • Individuals who are currently experiencing psychotic symptoms as part of an MDE (mood congruent/mood incongruent).
  • Individuals who are unable to consent to the procedure.
  • Individuals who are unable to adhere to the protocol in its totality

Treatment and study plan

Saliva Genetic Samples

Genetic

Patients will provide two saliva swabs containing genetic materials.

Primary outcomes

  1. Genetic Biomarkers

    Time frame: 1 month

    Genetic markers associated with metabolism of IV ketamine will be assessed

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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)

  4. 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.

  5. Diet Screener Questionnaire

    Time frame: 1 month

    Captures data regarding an individuals dietary habits over the past month

  6. 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).

  7. 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.

Sponsors and collaborators

Lead sponsor

Brain and Cognition Discovery Foundation

Other

Registry information

Official study title

Genetic Markers Associated With Response to Intravenous Ketamine

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 5, 2021
Registry last updated
Aug 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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