Status:
RECRUITING
A Study to Assess Effectiveness and Efficiency of VNS Therapy in Patients With Difficult to Treat Depression.
Lead Sponsor:
LivaNova
Conditions:
Treatment Resistant Depression
Eligibility:
All Genders
18+ years
Brief Summary
The primary objective of this study is to assess short, mid and long-term clinical outcomes in patients with difficult to treat depression (such as patients with treatment resistant depression) treate...
Detailed 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 f...
Eligibility Criteria
Inclusion
- Be at least 18 years of age.
- Have a documented primary diagnosis of chronic (\>2 years) or recurrent (2 or more prior episodes) major depressive episode that has not adequately responded to an adequate number of antidepressant treatments, as per local medical standards. This diagnosis must be confirmed using the MINI.
- Provide written Ethics Committee (EC) or Institutional Review Board (IRB) approved informed consent and Health Insurance Portability and Accountability Act (HIPAA, US only) authorization (as applicable according to local requirements).
- Currently is receiving at least one antidepressant treatment (i.e., antidepressant drug, maintenance electroconvulsive therapy, or formal psychotherapy including supportive psychotherapy) or mood stabilizing treatment for bipolar patients (such as lithium, anticonvulsants, or atypical antipsychotics).
- Able and willing to comply with the frequency of (outpatient) clinic visits and to reliably complete all the evaluations as specified in the study protocol.Hence based on the nature of their disease, the following patients should not be included: patients with mental retardation, current severe or significant substance/alcohol abuse, diagnosis of one or more schizophrenia-spectrum or other psychotic disorders, diagnosis of borderline or severe personality disorder as determined by clinical judgment which, in the investigator's opinion, would significantly interfere with subject's participation in the study)
Exclusion
- There are no exclusion criteria; the investigator should refer to the (local applicable) VNS Therapy Physician's Manual.
Key Trial Info
Start Date :
December 14 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2031
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT03320304
Start Date
December 14 2017
End Date
December 1 2031
Last Update
December 10 2025
Active Locations (18)
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1
AKH Allgemeines Krankenhaus der Stadt Wien
Vienna, Austria, 1090
2
KU Leuven
Leuven, Belgium
3
Sozialstiftung Bamberg - Klinikum am Bruderwald
Bamberg, Germany
4
Universitätsklinikum Bonn
Bonn, Germany