- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT06335043
Farmacoterapia personalizzata utilizzando la farmacogenetica nei veterani (PGx)
Farmacoterapia personalizzata utilizzando la farmacogenetica nei veterani che cercano un trattamento per la salute mentale
This study is an observational clinical trial aimed at to evaluate the use of pharmacogenetic testing (PGx) for mental health treatment in members and Veterans of the CAF and RCMP patient population as well as the attitudes of both St. Joseph's OSI Clinic Psychiatrists and patients towards PGx. Both OSI Clinic Psychiatrists participants and patient participants will be administered a brief demographic survey in addition to a survey examining their views on, and current knowledge of PGx. Patient participants will have an opportunity to opt-in to or opt-out of receiving PGx. For patient participants who opt-in to PGx (PGx-guided treatment group), a report summarizing the PGx results will be sent to each patient participants' respective OSI Clinic Psychiatrist, alongside a questionnaire that captures the OSI Clinic Psychiatrist participant's treatment planning and changes to treatment planning. Where applicable, past treatment data from patient participants acquired at the St. Joseph's OSI Clinic will be used to identify the number of prior medication changes. Patient participants who opt-out of PGx but continue to receive pharmacologic care at the St. Joseph's OSI Clinic will act as a standard care comparator treatment group. Patient participant's outcomes including PTSD, depression and anxiety severity, and medication-related side effects, will be assessed until the patient participant is discharged from the OSI Clinic or after 24 weeks, whichever comes first. All patient participants, regardless of their study treatment group, will have their symptomatology collected via standard care data collection protocol (Client Reported Outcomes Monitoring Information System (CROMIS) and electronic medical records (EMR)); a self-report assessing the presence of side effects will be completed via Lawson REDCap. OSI Clinic Psychiatrist participants and patient participants will be asked to complete a virtual exit interview at the end of their participation.
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Natalie Ein, PhD
- Numero di telefono: 416-573-9047
- Email: natalie.ein@sjhc.london.on.ca
Luoghi di studio
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Ontario
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London, Ontario, Canada, N6C 0A7
- Reclutamento
- MacDonald Franklin OSI Research and Innovation Centre
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Contatto:
- Natalie Ein, PhD
- Numero di telefono: 416-573-9047
- Email: natalie.ein@sjhc.london.on.ca
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
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Provider participant:
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Are at least 18 years of age;
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Speak and write English;
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Currently working as an OSI Clinic Psychiatrist at the London St. Joseph's OSI Clinic.
- Psychiatrist with an active caseload of patients being treated for OSIs.
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Patient participant:
- Veteran (patient) CAF or RCMP member;
- Are at least 18 years of age;
- Are a current patient at the London St. Joseph's OSI Clinic;
- Current diagnosis of an OSI;
- Speak and write English;
- Consents to the use of CROMIS data for the purpose of this study; and
- Consents to the use of prior OSI Clinic data for research purposes (if you have been a patient at the OSI Clinic prior to this study, the research team will use past OSI Clinic data to observe changes over time).
Exclusion Criteria:
- Participants (provider or patients) who are unable to, or do not, provide informed consent for participation.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Nessun intervento: Mental Health Provider
Mental health provider's thoughts on pharmacogenetic testing for treatment planning and changes to treatment planning. |
|
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Sperimentale: Patient with Pharmacogenetic Testing
For patient participants who opt-in to pharmacogenetic testing, a report summarizing the pharmacogenetic testing results will be sent to each patient participants' respective mental health provider. |
Genetic test to determine individual genetic compatibility with multiple pharmaceutical drug classes to determine best outcomes for prescription drug treatment. |
|
Nessun intervento: Patient without Pharmacogenetic Testing
For patient participants who opt-out to pharmacogenetic testing will be followed to see if treatment course is maintained. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
PHQ-9 - Patient Health Questionnaire 9
Lasso di tempo: 5 minutes
|
Objectifies degree of depression severity |
5 minutes
|
|
GAD-7 - General Anxiety Disorder-7
Lasso di tempo: 5 minutes
|
Measures severity of anxiety |
5 minutes
|
|
PCL-5 - Posttraumatic Stress Disorder Checklist - 5
Lasso di tempo: 5 minutes
|
A 20-item self-report tool that corresponds to the 20 symptoms listed in the DSM-V |
5 minutes
|
|
OQ-45 - Outcome Questionnaire 45
Lasso di tempo: 10 minutes
|
A 45-item multiple-choice self-report inventory used to measure psychotherapy progress in adult patients |
10 minutes
|
|
Pharmacological Side Effect Measure
Lasso di tempo: 10 minutes
|
To determine if the participant is experiencing any new or worsening or continuing side effects related to prescription medications |
10 minutes
|
|
Electronic Medical Record Extraction Measure
Lasso di tempo: 10 minutes
|
To determine trial and error attempts with pharmacological prescriptions in an attempt to minimize and/or control symptoms |
10 minutes
|
Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 119245
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .