Genetic markers associated with metabolism of IV ketamine will be assessed
Pharmacogenetics Associated With IV Ketamine
Brief Summary
Intervention / Treatment
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Saliva Genetic Samples (GENETIC)Patients will provide two saliva swabs containing genetic materials.
Condition or Disease
- Treatment Resistant Depression
Phase
Study Design
Study type: | OBSERVATIONAL |
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Status: | Completed |
Study results: | No Results Available |
Age: | 18 Years to 65 Years |
Enrollment: | 85 (ACTUAL) |
Time Perspective: | Prospective |
Observational Model: | Ecologic or Community |
Masking |
Clinical Trial Dates
Start date: | Jan 21, 2021 | ACTUAL |
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Primary Completion: | Jul 02, 2021 | ACTUAL |
Completion Date: | Jul 02, 2021 | ACTUAL |
Study First Posted: | Jan 05, 2021 | ACTUAL |
Last Updated: | Aug 12, 2021 |
Sponsors / Collaborators
Participant Groups
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Patients, who previously received intravenous ketamine, will be asked to provide genetic samples in order to assess relationships between response and genetic markers.
Eligibility Criteria
Sex: | All |
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Minimum Age: | 18 |
Maximum Age: | 65 |
Age Groups: | Adult / Older Adult |
Healthy Volunteers: | Yes |
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
Primary Outcomes
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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.
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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.
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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.
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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.
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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
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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.
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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.
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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)
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20 item Self report scale measuring loneliness. Scales range from 0 to 60 with higher scores indicating a higher level of loneliness.
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Captures data regarding an individuals dietary habits over the past month
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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).
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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.
More Details
NCT Number: | NCT04695405 |
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Other IDs: | Ket-PGx |
Study URL: | https://clinicaltrials.gov/study/NCT04695405 |