Clinical trial · Observational
PGx Medication Safety Reviews of Persons With IDD
Pharmacogenomic-Based Medication Safety Reviews of Persons With Intellectual and Developmental Disabilities
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to assess the feasibility of a comprehensive medication review and PGx initiative as part of the care process for individuals in the care of CP Unlimited. This initiative may help improve management of medications and overall health and well-being for participating individuals. Please note that in the context of the research being conducted, all information will remain confidential and deidentified for analyses. Under the proposed study protocol, CP Unlimited, in partnership with pharmacists at GalenusRx, will implement and assess a comprehensive medication safety and PGx initiative. Almost three quarters of all clinical trials have eligibility criteria resulting in the exclusion of adults with IDD. This study will help address ongoing health practice disparity. As indicated above, the investigators are requesting the authorization of the guardian or representative, on behalf of the participant under their supervision, to enroll this individual in the proposed study because she/he is currently prescribed medications or may eventually receive prescribed or over-the-counter medications. Hereinafter, the denomination "he/she, him/her, his/her or them/their" will be used to refer to the individual with IDD. The response to medication can be affected by variations in our genes and by other medications and various disease conditions. Information contained in our genes can vary from one patient to another patient and this can explain why we all can respond differently to medications. Genetic testing and a review of his/her medications can help to determine if the medication will work for him/her. PGx is how his/her genes affect the way he/she responds to specific drugs. PGx can tell if he/she is more or less likely to feel bad reactions to a drug, or if a drug is likely to benefit him/her and be safe for him/her to take. Knowing his/her genetic information and all medicines that he/she is taking can help his/her pharmacist and his/her doctor find the combination of medicines that will work the best for him/her, now and in the future.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Developmental Disability | — | UNRESOLVED | — |
| Intellectual Disability, Mild | — | UNRESOLVED | — |
| Intellectual Disability, Mild to Moderate | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cheek swab for PGx testing | Other | — | UNRESOLVED |
| Medication safety review | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Residents of CP Unlimited
- description
- All persons residing in CPU facilities during the study period will be included in the study, except those who are under 21 years of age, in whom a cheek swab cannot be obtained, and those who for whom no valid consent for participation is in place.
- interventionNames
- Other: Cheek swab for PGx testing
- Other: Medication safety review
Primary outcomes (2)
- measure
- Measure the Feasibility of PGx Testing in IDD Population
- timeFrame
- Two years
- description
- Measure feasibility of a PGx testing program calculating the number of pharmacogenetic tests / medication safety reviews completed.
- measure
- Measure the Acceptability of Implementing a PGx Program
- timeFrame
- Two years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Beneficiary with IDD * Reside in a CP Unlimited facility, NY state * At least 21 years of age Exclusion Criteria: * Pregnant * Medical or physical abnormality that prevents cheek swab collection
References
Publications (3)
- BACKGROUNDHolden B, Gitlesen JP. Psychotropic medication in adults with mental retardation: prevalence, and prescription practices. Res Dev Disabil. 2004 Nov-Dec;25(6):509-21. doi: 10.1016/j.ridd.2004.03.004. PMID 15541629
- BACKGROUNDDoan TN, Lennox NG, Taylor-Gomez M, Ware RS. Medication use among Australian adults with intellectual disability in primary healthcare settings: a cross-sectional study. J Intellect Dev Disabil. 2013 Jun;38(2):177-81. doi: 10.3109/13668250.2013.778968. Epub 2013 Apr 3. PMID 23550741
- BACKGROUNDAman MG, Lam KS, Van Bourgondien ME. Medication patterns in patients with autism: temporal, regional, and demographic influences. J Child Adolesc Psychopharmacol. 2005 Feb;15(1):116-26. doi: 10.1089/cap.2005.15.116. PMID 15741793