Pharmacogenetics Associated With IV Ketamine

Treatment Resistant Depression Clinical Trial

Official title:

Genetic Markers Associated With Response to Intravenous Ketamine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04695405
• Other study ID #: Ket-PGx
• Status: Completed
• Start date: January 21, 2021
• Est. completion date: July 2, 2021

Study information

• Verified date: August 2021
• Source: Brain and Cognition Discovery Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: July 2, 2021
• Est. primary completion date: July 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depressive Disorder, Treatment-Resistant
• Treatment Resistant Depression

Intervention

Genetic:
• Saliva Genetic Samples
Patients will provide two saliva swabs containing genetic materials.

Locations

Country	Name	City	State
Canada	Canadian Rapid Treatment Centre of Excellence	Mississauga	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Brain and Cognition Discovery Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genetic Biomarkers	Genetic markers associated with metabolism of IV ketamine will be assessed	1 month
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Work Productivity and Activity Impairment Questionnaire (WPAI)	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.	1 month
Secondary	Mystical Experience Questionnaire (MEQ)	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.	1 month
Secondary	Childhood Trauma Questionnaire (CTQ)	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)	1 month
Secondary	UCLA Loneliness Scale (UCLA)	20 item Self report scale measuring loneliness. Scales range from 0 to 60 with higher scores indicating a higher level of loneliness.	1 month
Secondary	Diet Screener Questionnaire	Captures data regarding an individuals dietary habits over the past month	1 month
Secondary	Quality of Life Questionnaire (EQ-3D-5L)	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).	1 month
Secondary	Perceived Health Questionnaire (PHQ)	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.	1 month