Trial results for a pharmacogenetic study in Depression were posted on ClinicalTrials.gov on 2025-06-29, involving 1572 participants and showing differences in depression remission rates between immediate and delayed pharmacogenetic testing groups.
Background
Depression is a prevalent mental health condition that significantly impacts quality of life. Current treatment approaches often involve a trial-and-error process with various antidepressant medications, which can be time-consuming and frustrating for patients. Pharmacogenetics (PGx) aims to personalize treatment by using an individual's genetic profile to predict their response to specific medications, potentially leading to more effective treatment choices and reduced adverse effects. This pragmatic trial explored the utility of pharmacogenetic testing in guiding treatment for depression.
Trial design
This completed study, identified as Phase NA, enrolled 1572 participants with Depression. The trial was part of a larger protocol investigating pharmacogenetics across multiple conditions, with this specific component focusing on depression. The study compared outcomes between two groups: one receiving immediate pharmacogenetic testing (Immediate PGx Testing) and another receiving delayed pharmacogenetic testing (Delayed PGx Testing). Key measurements included changes in depression symptom control, depression symptomatology, side effect burden, medication non-adherence, and the number of participants achieving depression remission, assessed using tools such as the Patient-Reported Outcomes Measurement Information System (PROMIS) and the Patient Health Questionnaire (PHQ-8).
Key results
The trial results indicate varying outcomes across different measures:
- For Change in Depression Symptom Control as Measured by PROMIS, the Immediate PGx Testing group showed a mean change of -4.3 T-score (Standard Deviation 8.4), while the Delayed PGx Testing group showed a mean change of -4.0 T-score (Standard Deviation 8.1). The mean difference between groups was -0.27 (95% CI: -1.54 to 1.0), with a p-value of 0.677.
- For Change in Depression Symptomatology as Measured by Patient Health Questionnaire (PHQ-8), the Immediate PGx Testing group had a mean change of -3.3 score (Standard Deviation 5.2), and the Delayed PGx Testing group had a mean change of -2.7 score (Standard Deviation 4.8). The mean difference was -0.6 (95% CI: -1.4 to 0.2), with a p-value of 0.1264.
- Regarding Side Effect Burden, the Immediate PGx Testing group reported a mean of 8.2 score (Standard Deviation 4.3), compared to 7.8 score (Standard Deviation 4.5) in the Delayed PGx Testing group. The mean difference was 0.3 (95% CI: -0.4 to 1.1), with a p-value of 0.3692.
- For Medication Non-Adherence as Measured by the Voils Medication Adherence Survey, 142 participants in the Immediate PGx Testing group and 137 participants in the Delayed PGx Testing group reported non-adherence. The Chi-squared analysis yielded a p-value of 0.8492.
- For Number of Participants With Depression Remission as Measured by PROMIS, 153 participants in the Immediate PGx Testing group achieved remission, compared to 122 participants in the Delayed PGx Testing group. The Chi-squared analysis showed a p-value of 0.0246.
- For Number of Participants With Depression Remission as Measured by the Patient Health Questionnaire (PHQ-8), 95 participants in the Immediate PGx Testing group achieved remission, versus 65 participants in the Delayed PGx Testing group. The Chi-squared analysis resulted in a p-value of 0.0111.
What this means
The results suggest that immediate pharmacogenetic testing may lead to a statistically significant difference in depression remission rates compared to delayed testing, as indicated by the p-values of 0.0246 for PROMIS and 0.0111 for PHQ-8 remission outcomes. This could imply a potential benefit of early PGx guidance in helping patients achieve remission. However, other key measures such as overall change in depression symptom control (PROMIS and PHQ-8), side effect burden, and medication non-adherence did not show statistically significant differences between the immediate and delayed testing groups. These findings highlight a specific impact on remission while suggesting that broader symptomatic improvements or reductions in side effects were not significantly altered within the scope of this study.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05966155, titled "A Depression and Opioid Pragmatic Trial in Pharmacogenetics (Depression Trial)", were posted on 2025-06-29 on clinicaltrials.gov.