About the Study
This study is evaluating a potential new oral treatment for adults with panic disorder, a mental health condition marked by sudden and repeated episodes of intense fear, often accompanied by physical symptoms like chest pain, shortness of breath, and rapid heartbeat.
The investigational treatment combines two approved medications that are not approved for panic attacks into a unique formulation designed to target brain pathways involved in the stress response, aiming to regulate the physiological and neurological factors that contribute to panic attacks. In earlier research, it showed promising results, including reduced panic attacks and good tolerability.
This clinical trial aims to assess the safety and effectiveness of this potential new oral treatment in adults aged 18–65 who experience panic attacks but are not currently taking benzodiazepines or affected by other major psychiatric disorders.
Who Can Participate
- Aged 18–65
- Experienced 2+ panic attacks in the past 6 weeks
- If female, are currently using a form of contraception
- No diagnosis of OCD, bipolar disorder, or schizophrenia
- No history of depression-related hospitalisation or suicide attempts
- Not currently using benzodiazepines
- Stable medical conditions and medication dosages for the past 3 months
What to Expect During Study Participation
Participation in the study lasts approximately 14 weeks and involves:
- 6 in-person clinic visits
- 1 phone call
- 8 video calls
All visits will be scheduled during our regular business hours: Monday to Friday, 9am–5pm.
During these visits, participants will undergo health assessments including:
- Physical exams and vital sign checks
- ECGs (heart monitoring)
- Blood tests
- Pregnancy tests (if applicable)
- Urine drug tests
- Health questionnaires
Our study doctor and team will also review previous research on the treatment and discuss potential risks or benefits of participating. Visits will range from 30 minutes to 2.5 hours in length.
Study Medication
Participants will take one oral tablet per day for 12 weeks. This is a placebo- and comparator-controlled trial with four different study groups. Each participant will be randomly assigned to one group. The study is blinded, meaning neither the participants nor study doctors will know which group they are in, ensuring unbiased results.
