An interventional study of Comprehensive medication management with PGx testing results and Usual Care in Pharmacogenetics, Depression - Major Depressive Disorder and Pharmacogenomic Drug Interaction, sponsored by University of Pittsburgh. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Health services research
Among 105 studies in Depression by University of Pittsburgh — 15 open to participants now, 17 under way, none of them phase 3. Depression · University of Pittsburgh.
Among the 105 studies in Depression by University of Pittsburgh, this one is the 25th largest by planned enrollment of the 98 interventional ones, is one of 3 that started in 2026, is one of 72 with no phase, reaches primary completion later than 1 of the 16 other live ones, and was the 105th registered.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 220 is above the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →15 of the 105 studies in Depression by University of Pittsburgh are open now, in 1 country. Each count lists the studies.
Of the 1,088 Depression studies recruiting now, 469 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 310 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →105 studies; the count open now beside each. This study's row is marked.
First in 1983; this study’s year is marked. 3 started in 2026.
Median enrollment 90 across the 98 interventional studies, 80 across the 6 observational. Of the 85 that completed or were terminated, 29 (34%) have results posted.
University of Pittsburgh is the lead sponsor of 1,419 studies on the registry; 168 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
8 of the studies in Depression by University of Pittsburgh that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05658796University of PittsburghRXWell to Decrease Post-Operative Opioid Use in Total Knee or Hip Arthroplasty | 2026-12-01 |
| NCT06835985University of PittsburghSocial Media Intervention for Online Victimized Youth | 2026-12-30 |
| NCT07373470University of PittsburghAn Evaluation of the Impact of Pharmacist Comprehensive Medication Management With Pharmacogenomic Results to Improve Depression Outcomes in Community Pharmacies. | 2026-12-31 |
| NCT06829953University of PittsburghGet ActivE Study for At-risk Youth | 2026-12-31 |
| NCT06963463University of PittsburghTransdiagnostic Sleep and Circadian Intervention + Bright Light in Adolescents With Elevated Depression (TranS-C+BL) | 2026-12-31 |
Among the 105 studies in Depression by University of Pittsburgh, from their registry updates:
Nothing recorded among them since 2026-09-25.
The goal of this prospective, randomized clinical trial is to learn whether pharmacogenomic (PGx)-guided comprehensive medication management delivered by pharmacists in community pharmacies will improve antidepressant treatment outcomes.
The primary aim is to determine whether comprehensive medication management with review of PGx testing results improves depression symptoms, compared with usual care.
Participants 18 years of age or older who have undergone PGx testing (e.g. through an independent biobanking study (Pitt+Me Discovery) who require initiation or adjustment of antidepressant therapy will be randomly assigned to receive either PGx-guided comprehensive medication management or usual care. Those who receive usual care will receive their PGx results at the end of the study. Researchers will compare the groups to assess whether PGx-guided care provided in partnership with community pharmacists and prescribers results in better depression and medication outcomes.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
At targeted community pharmacy for:
EXCLUSION CRITERIA:
Participants will have a study visit with a community pharmacist for comprehensive medication management with review of PGx testing results.
Other: Comprehensive medication management with PGx testing results
Participants will receive no study intervention (usual care) and will have a comprehensive medication management with review of PGx testing results at the end of the study.
Other: Usual Care
A comprehensive medication management with PGx testing includes a pharmacist-provided review of health history, past/current medications, and assessment of potential medication related problems. A review of PGx testing results will be integrated to identify any PGx-related medication issues. Recommendations will then be made to study participants' providers (regular care team) for any decisions regarding potential therapy changes.
Participants will receive no study intervention (usual care) and will have a comprehensive medication management with review of PGx testing results at the end of the study.
Change in Patient Health Questionnaire (PHQ-8) score
The Patient Health Questionnaire-8 (PHQ-8) is an 8-item self-report measure assessing depressive symptoms. Each item is scored from 0-3, producing a total score of 0-24, with higher scores indicating more severe depressive symptoms. Standard severity categories are minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-24).
Time frame: Baseline, 6 Weeks, 12 Weeks, 6 Months
Change in the Extent of Adherence and Reasons for Nonadherence Survey (Voils et al.) score
The Extent of Adherence and Reasons for Nonadherence Survey (Voils et al.) is a validated self-report measure assessing medication adherence over the past 7 days. It is scored on a 1-5 Likert scale and averaged to produce a continuous score, with higher scores indicating better adherence. The Reasons for Nonadherence scale assesses specific barriers to taking medication as prescribed, with items rated on a 1-5 scale and assessed individually to identify the degree to which each barrier contributed to missed doses.
Time frame: Baseline, 6 Months
Change in Generalized Anxiety Disorder Assessment (GAD-7) score
The Generalized Anxiety Disorder Assessment (GAD-7) is a 7-item self-report measure assessing anxiety symptoms over the past two weeks, with items scored 0-3 for a total score of 0-21; higher scores indicate more severe anxiety, categorized as minimal (0-4), mild (5-9), moderate (10-14), and severe (15-21).
Time frame: Baseline, 6 Weeks, 12 Weeks, 6 Months
Proportion of pharmacist recommendations were accepted
Proportion of pharmacist recommendations to address medication-related problems that were accepted by providers as assessed by EHR and fill data review.
Time frame: 6 months
Change in frequency of CPIC/FDA guideline concordant prescribing
Change in frequency of concordance of participant medication regimen with pharmacogenomics prescribing recommendations according to the Clinical Pharmacogenomics Implementation Consortium (CPIC) and U.S. Food \& Drug Administration (FDA) guidelines using electronic health record data.
Time frame: Baseline, 6 Months
Number of adverse events as assessed using the Frequency, Intensity, and Burden of Side Effect rating scale (FIBSER).
The Frequency, Intensity, and Burden of Side Effect Rating Scale (FIBSER) is a 3-item self-report measure assessing medication side effects. It evaluates the frequency, intensity, and functional burden of side effects over the past week, with each item rated on a 0-6 scale; higher scores indicate more frequent, severe, or burdensome side effects. Clinically, a total score of 0-2 typically requires no change in treatment, 3-4 side effects may warrant targeted management, and 5-6 indicates that treatment modification should be considered to improve tolerability and adherence.
Time frame: Baseline, 6 Weeks, 12 Weeks, 6 Months
Frequency of Actionable Genotypes
Frequency of actionable genotypes (in the entire study population) based on report of a genotype-predicted phenotype. Actionable genotypes are defined as those with recommendations for a change in prescribing by a CPIC (Clinical Pharmacogenetics Implementation Consortium) guidelines or FDA recommendations.
Time frame: 6 months
Number of participant medications with PGx guidance based on PGx testing results.
This measure counts the number of a participant's medications for which pharmacogenomic (PGx) guidance is available based on PGx testing results. Medications with PGx guidance may have dosing recommendations, alternative drug options, or monitoring considerations informed by the participant's genetic profile.
Time frame: 6 months
Change in healthcare utilization
Change in participant ER visits, hospitalizations, urgent care visits, specialist appointments, primary care appointments, and unplanned care using UPMC EHR data.
Time frame: From Baseline to 6 Months
Community pharmacists' needs for expert support in deploying PGx
Community pharmacists' needs for expert support in deploying PGx Number and types of questions asked by community pharmacists to PGx experts on study team through the duration of the study.
Time frame: 6 Months
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Dec 2026, 3 months after the start.
Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 3 months is below that.
Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
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