Key Takeaways
Extended Takeaways
- In this symptomatic comorbid population, ADHD improvement was substantial by week 14/EOS, with mean (SD) AISRS and ASRSv1.1-SC total score changes of −17.3 (11.34) and −28.4 (14.89), and 71.8% and 45.6% of participants achieved ≥30% and ≥50% AISRS reduction, respectively.
- Mood and anxiety outcomes also crossed clinically relevant thresholds by week 14/EOS: ≥50% reduction was achieved by 57.5% on MADRS, 78.4% on PHQ-8, 70.8% on HAM-A, and 67.6% on GAD-7, with remission rates of 28.3%, 48.6%, 24.2%, and 43.2%, respectively.
- The study reflects common real-world polypharmacy rather than monotherapy use alone: 28.6% of participants took stimulants, 44.7% took antidepressants, and 14.9% took anxiolytic and/or hypnotic medications during treatment.
- Functional gains extended beyond symptom scales, with significant improvement at week 14/EOS in WPAI:SHP domains including presenteeism (mean [SD] change, −23.08 [26.072; P<.0001]), regular activity (−36.06 [24.230; P<.0001]), and work productivity (−22.32 [26.915; P<.0001]).
- Tolerability monitoring should emphasize early adverse effects and suicidality: TEAEs occurred in 70.8%, 14.9% discontinued because of TEAEs, and 5 participants (3.1%) reported TEAEs of suicidal ideation, including 2 serious cases on day 3 of study treatment.
- Cardiovascular changes were usually modest but not negligible, with 20.0% showing a >15 mm Hg increase in SBP, 13.3% a >15 mm Hg increase in DBP, and 10.2% a >20 beats per minute increase in pulse rate at week 14/EOS, even though related TEAEs were uncommon.
