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History of Changes for Study: NCT04695405
Pharmacogenetics Associated With IV Ketamine
Latest version (submitted August 12, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 3, 2021 None (earliest Version on record)
2 August 12, 2021 Recruitment Status, Study Status, Study Design and Contacts/Locations
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Study NCT04695405
Submitted Date:  January 3, 2021 (v1)

Open or close this module Study Identification
Unique Protocol ID: Ket-PGx
Brief Title: Pharmacogenetics Associated With IV Ketamine
Official Title: Genetic Markers Associated With Response to Intravenous Ketamine
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2021
Overall Status: Not yet recruiting
Study Start: January 2021
Primary Completion: August 2021 [Anticipated]
Study Completion: August 2021 [Anticipated]
First Submitted: December 28, 2020
First Submitted that
Met QC Criteria:
January 3, 2021
First Posted: January 5, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
January 3, 2021
Last Update Posted: January 5, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Brain and Cognition Discovery Foundation
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Treatment Resistant Depression
Keywords:
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Ecologic or Community
Time Perspective: Prospective
Biospecimen Retention: Samples With DNA
Biospecimen Description: Patients will provide two saliva samples containing genetic information.
Enrollment: 150 [Anticipated]
Number of Groups/Cohorts 1
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
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.
Genetic: Saliva Genetic Samples
Patients will provide two saliva swabs containing genetic materials.
Open or close this module Outcome Measures
Primary Outcome Measures:
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 Outcome Measures:
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.
Open or close this module Eligibility
Study Population: All participants will have received IV ketamine previously for treatment resistant depression, as defined by the DSM-5
Sampling Method: Non-Probability Sample
Minimum Age: 18 Years
Maximum Age: 65 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: Nelson Rodrigues, MSc
Telephone: 416-430-9619
Email: nelson.rodrigues@crtce.com
Study Officials: Joshua D Rosenblat, MD, MSc
Principal Investigator
Canadian Rapid Treatment Center of Excellence
Locations: Canada, Ontario
Canadian Rapid Treatment Centre of Excellence
Mississauga, Ontario, Canada, L5C 4E7
Open or close this module IPDSharing
Plan to Share IPD: No
Individual participant data will not be shared due to confidentiality. Only aggregate data will be published or made available.
Open or close this module References
Citations:
Links:
Available IPD/Information:

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