Conditions: Generalized Anxiety Disorder (GAD) Anxiety, Separation Phobia, Social
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 83
Healthy volunteers: no

Brief summary:
This study will evaluate the safety and tolerability of SPD503 in subjects aged 6-17 years with GAD, SAD, or SoP based on treatment emergent adverse events (TEAEs), vital signs and ECGs.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: SPD503 (extended-release Guanfacine hydrochloride) intervention 2: Placebo
Intervention descriptions: intervention 1: Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks (6 week dose optimization and 6 week dose maintenance). intervention 2: Once-daily oral dosing in the evening for 12 weeks.

Protocol document: