Pharmacogenetics Associated With IV Ketamine

NCT04695405 | Completed

• 1 other identifier: Ket-PGx
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Treatment Resistant Depression

Outcome Measures

Primary Outcomes (6)

• Genetic Biomarkers

  Genetic markers associated with metabolism of IV ketamine will be assessed

  1 month

• Quick Inventory of Depressive Symptomatology Self Report 16-Item

  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.

  Over 1-2 weeks

• Generalized Anxiety Disorder 7-item

  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.

  Over 1-2 weeks

• Snaith-Hamilton Pleasure Scale

  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.

  Over 1-2 weeks

• Sheehan Disability Scale

  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.

  Over 4 initial infusions

• Clinician Administered Dissociative States Scale

  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.

  Over 1-2 weeks

Secondary Outcomes (7)

• Work Productivity and Activity Impairment Questionnaire (WPAI)

  1 month

• Mystical Experience Questionnaire (MEQ)

  1 month

• Childhood Trauma Questionnaire (CTQ)

  1 month

• UCLA Loneliness Scale (UCLA)

  1 month

• Diet Screener Questionnaire

  1 month

Study Arms (1)

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

Interventions

Saliva Genetic Samples GENETIC

Patients will provide two saliva swabs containing genetic materials.

Treatment-Resistant Depression

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brain and Cognition Discovery Foundation: lead

Study Sites (1)

Canadian Rapid Treatment Centre of Excellence

Mississauga, Ontario, L5C 4E7, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Patients will provide two saliva samples containing genetic information.

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Joshua D Rosenblat, MD, MSc

  Canadian Rapid Treatment Center of Excellence

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2020
• First Posted: January 5, 2021
• Study Start: January 21, 2021
• Primary Completion: July 2, 2021
• Study Completion: July 2, 2021
• Last Updated: August 18, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)