NCT02395510

A 10-Week, Open-Label, Flexible Dose Adaptive Study Evaluating the Efficacy of Vortioxetine in Subjects With Panic Disorder

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Siyan Clinical Corporation · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The primary aim of this study is to evaluate the efficacy of Vortioxetine in an adult population with a diagnosis of PD. PD is generally treated with benzodiazepines which are very effective but have a high risk for addiction, fall, and cognitive impairment. There is still a need for better treatment for PD for longer term use. There are other drugs within the SSRI/SNRI class which have proven to be effective in treating patients with this diagnosis.

Detailed description

The primary objective of the study is to evaluate the efficacy of Vortioxetine (5, 10, or 20mg) over a period of 10 weeks in subjects with PD, with or without Agoraphobia. The efficacy of Vortioxetine will be evaluated using the Mean Change from Baseline in the Panic Disorder Severity Scale (PDSS) score and the reduction in occurrence of panic attacks as measured by item 1 in the PDSS Scale after 10 weeks of treatment with Vortioxetine. This study is an open-label, adaptive study with flexible dose strategies lasting 10 weeks. Approximately 20 male and female subjects over the age of 18aged 18-60 years who currently meet DSM-IV criteria for PD with or without Agoraphobia or who have a PDSS score \> 8 at Baseline will be enrolled in this study.

Conditions

• Panic Disorder

Interventions

Type	Name	Description
DRUG	Vortioxetine	Vortioxetine 5-20mg

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2015-03-23
• Last updated: 2016-07-25

Locations

1 site across 1 country: United States