A Study to Assess Effectiveness and Efficiency of VNS Therapy in Patients With Difficult to Treat Depression.
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Treatment Resistant Depression
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The population under study comprises a real-world patient population with difficult to treat depression: patients diagnosed with unipolar or bipolar disorder with chronic or recurrent depression who fail to achieve an adequate response to standard psychiatric management. The diagnosis of depression ...
The population under study comprises a real-world patient population with difficult to treat depression: patients diagnosed with unipolar or bipolar disorder with chronic or recurrent depression who fail to achieve an adequate response to standard psychiatric management. The diagnosis of depression and comorbid disorders will be determined based on the Mini International Neuropsychiatric Interview (MINI). A minimum of five hundred (500) patients will be implanted with a VNS Therapy System and up to eighty (80) sites may participate in this study. Enrollment will take maximum 5 years, based on competitive enrollment. For each subject a baseline visit will occur between 1 and 6 weeks before implant. Once implanted with the device, subjects will be followed-up for a minimum of 36 months and a maximum of 60 months.The study may stop when the last subject has reached the 36 months follow-up.
Tracking Information
- NCT #
- NCT03320304
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Koen Demyttenaere, Prof. KU Leuven Principal Investigator: Allan Young, Prof. King's College