Study Information
Generalised anxiety disorder can affect emotional wellbeing, concentration, and daily functioning, and many people living with anxiety also experience ongoing sleeping difficulty. Sleep problems can further worsen anxiety symptoms and impact overall quality of life.
This clinical research study is evaluating an investigational oral medicine for adults living with generalised anxiety disorder who also experience insomnia or poor sleep. Researchers are studying whether this investigational treatment may help improve anxiety and sleep symptoms, while closely monitoring safety and tolerability.
Who is it for?
You may be suitable if you:
- Are aged 18 to 65 years
- Meet DSM-5 diagnostic criteria for generalized anxiety disorder
- Experience clinically significant insomnia or sleep difficulties
- Are able to attend study visits and complete study procedures
- Are able to commit to the full study duration (approximately 11 weeks)
What does study participation look like?
If suitable, participation lasts approximately 11 weeks and includes:
- A screening period
- A 6-week treatment phase
- A short follow-up period
Participants will take a once-daily oral study medication, attend scheduled clinic visits, complete questionnaires related to anxiety and sleep, and undergo routine health and safety assessments. The study also includes at-home sleep monitoring using a wearable device to assess sleep patterns.
Clinic visits will take place on weekdays between 9:00 am and 5:00 pm. Visit length may vary depending on the assessments required.