- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT06335043
Personlig tilpasset farmakoterapi ved bruk av farmakogenetikk hos veteraner (PGx)
Personlig tilpasset farmakoterapi ved bruk av farmakogenetikk hos veteraner som søker behandling for mental helse
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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Natalie Ein, PhD
- Telefonnummer: 416-573-9047
- E-post: natalie.ein@sjhc.london.on.ca
Studiesteder
-
-
Ontario
-
London, Ontario, Canada, N6C 0A7
- Rekruttering
- MacDonald Franklin OSI Research and Innovation Centre
-
Ta kontakt med:
- Natalie Ein, PhD
- Telefonnummer: 416-573-9047
- E-post: natalie.ein@sjhc.london.on.ca
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
-
Provider participant:
-
Are at least 18 years of age;
-
Speak and write English;
-
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.
-
-
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Mental Health Provider
Mental health provider's thoughts on pharmacogenetic testing for treatment planning and changes to treatment planning. |
|
|
Eksperimentell: 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. |
|
Ingen inngripen: Patient without Pharmacogenetic Testing
For patient participants who opt-out to pharmacogenetic testing will be followed to see if treatment course is maintained. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
PHQ-9 - Patient Health Questionnaire 9
Tidsramme: 5 minutes
|
Objectifies degree of depression severity |
5 minutes
|
|
GAD-7 - General Anxiety Disorder-7
Tidsramme: 5 minutes
|
Measures severity of anxiety |
5 minutes
|
|
PCL-5 - Posttraumatic Stress Disorder Checklist - 5
Tidsramme: 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
Tidsramme: 10 minutes
|
A 45-item multiple-choice self-report inventory used to measure psychotherapy progress in adult patients |
10 minutes
|
|
Pharmacological Side Effect Measure
Tidsramme: 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
Tidsramme: 10 minutes
|
To determine trial and error attempts with pharmacological prescriptions in an attempt to minimize and/or control symptoms |
10 minutes
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 119245
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .