Poster
135
(#135) Sleep outcomes in a decentralized trial of viloxazine ER in adults with ADHD and depression and/or anxiety symptoms
Psych Congress 2025
Abstract: OBJECTIVE: We previously reported improvement in ADHD, depression and anxiety symptom rating scales in a "real-world," open-label decentralized trial of viloxazine ER (Qelbree®) in adults with ADHD and comorbid depression and/or anxiety symptoms [NCT06185985]. Sleep problems commonly occur in both ADHD and depression. Here we evaluate changes in sleep quality from this study, rated using the Pittsburgh Sleep Quality Index (PSQI).
METHODS: Participants (n=161, 75.8% female, mean age 39.4 years), recruited primarily via social media, were required to have a primary diagnosis of ADHD (confirmed by MINI-AS), ADHD Investigator Symptom Rating Scale score ≥24, Clinical Global Impression of Severity for ADHD ≥3, and MADRS and/or HAM-A score >22. Viloxazine ER (200-600 mg/day) was added to existing medications for 14 weeks. Participants completed the PSQI (secondary outcome) at baseline and Week 14/end of study (EOS).
RESULTS: Mean±SD PSQI global scores were 10.8±3.29 (n=150) at baseline and 8.7±4.23 (n=90) at week 14/EOS, representing an improvement of -2.2±4.05 or 19.44% (P 0.0001). Threshold analysis showed 5-fold improvement in the proportion of participants reporting "good" sleep quality (PSQI global score ≤5), from 6% at baseline to 30% at endpoint, and 10-fold improvement in the proportion reporting no sleep problems (all PSQI component scores ≤1), from 2% at baseline to 20% at endpoint. Sleep-related adverse events included insomnia (19.3%), fatigue (9.3%), and somnolence (9.3%).
CONCLUSIONS: Viloxazine ER addition to current medications was associated with improvement in sleep outcomes in this decentralized trial in adults with ADHD and depression and/or anxiety symptoms.
Short Description: We previously reported improvement in ADHD, depression and anxiety symptom rating scales in a "real-world," open-label decentralized trial of viloxazine ER (Qelbree®) in adults with ADHD and comorbid depression and/or anxiety symptoms [NCT06185985]. Sleep problems commonly occur in both ADHD and depression. Here we evaluate changes in sleep quality from this study, rated using the Pittsburgh Sleep Quality Index (PSQI).
Name of Sponsoring Organization(s): Supernus Pharmaceuticals, Inc.
METHODS: Participants (n=161, 75.8% female, mean age 39.4 years), recruited primarily via social media, were required to have a primary diagnosis of ADHD (confirmed by MINI-AS), ADHD Investigator Symptom Rating Scale score ≥24, Clinical Global Impression of Severity for ADHD ≥3, and MADRS and/or HAM-A score >22. Viloxazine ER (200-600 mg/day) was added to existing medications for 14 weeks. Participants completed the PSQI (secondary outcome) at baseline and Week 14/end of study (EOS).
RESULTS: Mean±SD PSQI global scores were 10.8±3.29 (n=150) at baseline and 8.7±4.23 (n=90) at week 14/EOS, representing an improvement of -2.2±4.05 or 19.44% (P 0.0001). Threshold analysis showed 5-fold improvement in the proportion of participants reporting "good" sleep quality (PSQI global score ≤5), from 6% at baseline to 30% at endpoint, and 10-fold improvement in the proportion reporting no sleep problems (all PSQI component scores ≤1), from 2% at baseline to 20% at endpoint. Sleep-related adverse events included insomnia (19.3%), fatigue (9.3%), and somnolence (9.3%).
CONCLUSIONS: Viloxazine ER addition to current medications was associated with improvement in sleep outcomes in this decentralized trial in adults with ADHD and depression and/or anxiety symptoms.
Short Description: We previously reported improvement in ADHD, depression and anxiety symptom rating scales in a "real-world," open-label decentralized trial of viloxazine ER (Qelbree®) in adults with ADHD and comorbid depression and/or anxiety symptoms [NCT06185985]. Sleep problems commonly occur in both ADHD and depression. Here we evaluate changes in sleep quality from this study, rated using the Pittsburgh Sleep Quality Index (PSQI).
Name of Sponsoring Organization(s): Supernus Pharmaceuticals, Inc.
