Pharmacogenomics-Supported Psychotropic Prescribing Trial
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Pharmacogenetic Testing.
- Кому может быть актуально
- Состояния в реестре: Mental Disorder, Pharmacogenetics, Adverse Drug Reaction (ADR), Effectiveness. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Канада
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Pharmacogenomics-Supported Psychotropic Prescribing Trial (PGx-SUPPORT): A Pilot Implementation Study in Manitoba
Обзор
Investigate the feasibility and utility of implementing pharmacogenetic testing for adults (aged 18 and older) seeking care for mental illness in Manitoba.
Подробное описание
Background and Rationale: Pharmacogenomic (PGx) testing utilizes genetic information as a surrogate marker of a person's ability to process and react to drugs. This information can be used to inform medication selection and dosing, reducing the number of trials needed to choose a suitable medicine. For Manitoba healthcare providers, the only access to psychiatric PGx testing is through commercial providers, costing patients $200 to $2,300. To the best of our knowledge, no study in Manitoba has previously evaluated the feasibility of PGx testing in adult patients seeking care for mental illness.
RESEARCH OBJECTIVES: We aim to investigate the feasibility and utility of implementing PGx testing in Manitoba for adult patients seeking care for mental illness.
Primary Outcome and Measures: Feasibility will be measured along four dimensions:
* Acceptability (satisfaction surveys - patient \& clinician) * Practicality (testing turnaround time) * Implementation (clinicians' self-reported use of testing results in the prescribing decision-making process) * Demand (number of referrals, clinicians' self-reported intent to use testing in the future)
Secondary Outcomes and Measures:
* Changes in global functioning and symptom severity \[Clinical Global Impression (CGI) - Severity and Improvement; Brief Psychiatric Rating Scale (BPRS); DSM-5-TR Self-Rated Level 1 Cross-Cutting Symptom Measure; Patient Health Questionnaire-9 (PHQ-9); General Anxiety Disorder-7 (GAD-7); Altman Self-Rating Mania Scale (ASRM); Early Psychosis Screener (EPS-26)\] * Adverse drug experience \[Frequency, Intensity, Burden of Side Effects Rating (FIBSER)\] * Impact of PGx testing \[Changes in medication prescribing and dispensing patterns; changes in healthcare utilization (e.g., inpatient length of stay, mental health resource use, and utilization of healthcare services)
Expected Outcomes: The findings from the proposed study will inform policymakers and facilitate decision-making and priority-setting related to implementing PGx-based psychotropic prescribing policies in Manitoba
Вмешательства
- Диагностический тест Pharmacogenetic Testing
Participants will donate a 1ml (one-fifth of a teaspoon) sample of saliva. DNA extracted from the saliva sample will be used for genotyping. Genotyping results will be translated into an interpretative clinical report using evidence-based software (Sequence2Script) and delivered to the treating physician for use in their clinical decision-making. The report will contain genotyping results, predicted phenotype, and evidence-based drug selection and dosing recommendations relevant to the patient's
Первичные конечные точки
- Testing Acceptibility [Срок оценки: 3 months after after baseline.]
- Implementation Practicality [Срок оценки: Up to 3 Months]
- Implementation Feasibility [Срок оценки: Patient discharge date [within 3 months of baseline].]
- Test Demands [Срок оценки: Patient discharge date [within 3 months of baseline].]
Вторичные конечные точки (10)
- Clinical Global Impression Scale (CGI) - Severity [Срок оценки: Baseline]
- Clinical Global Impression Scale (CGI) - Improvement [Срок оценки: 3 months after baseline.]
- Brief Psychiatric Rating Scale (BPRS) [Срок оценки: Baseline and patient discharge date, within 3 months.]
- DSM-5-TR Self-Rated Level 1 Cross-Cutting Symptom Measure - Adult [Срок оценки: Baseline and 3 months after baseline.]
- General Anxiety Disorder-7 (GAD-7) [Срок оценки: Baseline and 3 months after baseline.]
- Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: Baseline and 3 months after baseline.]
- Altman Self-Rating Mania Scale (ASRM) - Adult [Срок оценки: Baseline and 3 months after baseline.]
- The Early Psychosis Screener (EPS-26) [Срок оценки: Baseline and 3 months after baseline.]
- Frequency, Intensity, Burden of Side Effects Rating (FIBSER) [Срок оценки: Baseline (if applicable) and 3 months after baseline.]
- Healthcare Utlization [Срок оценки: 1 year]
Критерии участия
Критерии включения
- Aged 18 years or older
- The initiation, change, dose adjustment, or augmentation of psychotropic medication(s) is indicated
- The treating clinician thinks PGx testing can benefit and refers the patient to the study
Критерии исключения
- Unwillingness to donate saliva samples for genetic analysis
- History of liver or bone marrow (hematopoietic cell) transplantation
- PGx testing results are already available
- No personal health identification number (PHIN) is available
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Поддерживающая терапия
Центры проведения
Канада · 2 центра
- Shared Health Facilities — Winnipeg
- University of Manitoba College of Pharmacy — Winnipeg
Идентификаторы
NCT: NCT06929533 · HS26637 (HS2024:279)