Abstract
The pharmacological treatment of depression consists of stages of trial and error, with less than 40% of patients achieving remission during first medication trial. However, in a large, randomized-controlled trial (RCT) in the U.S. (“GUIDED”), significant improvements in response and remission rates were observed in patients who received treatment guided by combinatorial pharmacogenomic testing, compared to treatment-as-usual (TAU). Here we present results from the Canadian “GAPP-MDD” RCT. This 52-week, 3-arm, multi-center, participant- and rater-blinded RCT evaluated clinical outcomes among patients with depression whose treatment was guided by combinatorial pharmacogenomic testing compared to TAU. The primary outcome was symptom improvement (change in 17-item Hamilton Depression Rating Scale, HAM-D17) at week 8. Secondary outcomes included response (≥50% decrease in HAM-D17) and remission (HAM-D17 ≤ 7) at week 8. Numerically, patients in the guided-care arm had greater symptom improvement (27.6% versus 22.7%), response (30.3% versus 22.7%), and remission rates (15.7% versus 8.3%) compared to TAU, although these differences were not statistically significant. Given that the GAPP-MDD trial was ultimately underpowered to detect statistically significant differences in patient outcomes, it was assessed in parallel with the larger GUIDED RCT. We observed that relative improvements in response and remission rates were consistent between the GAPP-MDD (33.0% response, 89.0% remission) and GUIDED (31.0% response, 51.0% remission) trials. Together with GUIDED, the results from the GAPP-MDD trial indicate that combinatorial pharmacogenomic testing can be an effective tool to help guide depression treatment in the context of the Canadian healthcare setting (ClinicalTrials.gov NCT02466477).
Highlights
The pharmacological treatment of depression consists of stages of trial-and-error prescribing, with less than 40% of patients achieving remission during their first medication trial and declining remission rates with each subsequent trial [1]
Among patients with major depressive disorder (MDD) who failed at least one previous medication trial, the Genomics Used to Improve DEpression Decisions (GUIDED) trial demonstrated that combinatorial pharmacogenomic testing was associated with significant relative increases in both response (31%) and remission (51%) rates, compared to treatment-as-usual (TAU) [14]
Gene-drug interaction refers to genetic variation that is predicted to impact the pharmacokinetics or RESULTS Cohort description Study enrollment and follow-up for patients in the PP and ITT cohorts are presented in CONSORT diagrams (Supplementary Figs 1, 2)
Summary
The pharmacological treatment of depression consists of stages of trial-and-error prescribing, with less than 40% of patients achieving remission during their first medication trial and declining remission rates with each subsequent trial [1]. Among patients with major depressive disorder (MDD) who failed at least one previous medication trial, the Genomics Used to Improve DEpression Decisions (GUIDED) trial demonstrated that combinatorial pharmacogenomic testing was associated with significant relative increases in both response (31%) and remission (51%) rates, compared to treatment-as-usual (TAU) [14]. The GAPP-MDD trial evaluated clinical outcomes when treatment was guided by a combinatorial pharmacogenomic test (guided-care) compared to intervention arm included patients for whom providers received the standard combinatorial pharmacogenomic test report to guide treatment (GEN arm). The GAPP-MDD trial (ClinicalTrials.gov: NCT02466477) was a 52-week, threearm, multi-center, patient- and rater-blinded, randomized, controlled trial Participants evaluating clinical outcomes among patients whose treatment was guided by The detailed inclusion and exclusion criteria are described in the combinatorial pharmacogenomic testing compared to TAU. Gene-drug interaction refers to genetic variation that is predicted to impact the pharmacokinetics or
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