Treatment Resistant Depression and Vagus Nerve Stimulation
Depression is a common illness, affecting 17% of the population over the course of a lifetime. A third of depressions relapses and progresses to recurrence and resistance to treatments. Despite the optimization of antidepressant medical strategies, 20 to 40% of depressions do not respond to treatment. This is particula
| Condition(s) | Treatment Resistant Depression (TRD) |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | Depression is a common illness, affecting 17% of the population over the course of a lifetime. A third of depressions relapses and progresses to recurrence and resistance to treatments. Despite the optimization of antidepressant medical strategies, 20 to 40% of depressions do not respond to treatment. This is particularly worrying as 6% of non-responder patients will die by committing suicide. Depression has a major impact on quality of life, socio-professional functioning and healthcare consumption. Sometimes, TRD is part of a bipolar illness. In this case, the challenge is even bigger because antidepressants are no well tolerated, further reducing the therapeutic options in case of resistance, the severity and duration of the depressive episodes are the main factors explaining the deteri |
| Who can participate | Inclusion Criteria: * Patients aged 18 years and older ; * Childbearing women must have an efficient contraception for the whole study period * Diagnosis of recurrent depressive trouble or persistent depressive disorder or bipolar disorder (according to DSM-5) * Start of disorder (defined by the occurrence of the first thymus episode: characterized depressive disorder or maniac episode with or without mixed characteristics) for 5 years or more * At least one of the following criteria: * Criterion A: current characterized depressive disorder and characterized depressive disorder for at least 12 months during the last 24 months despite at least four treatments lines at appropriate dosage and duration * Criterion B: current treatment by ECT and criteria A before the start of the ECT treatment |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
| Locations | Angers, France; Bordeaux, France; Caen, France; Clermont-Ferrand, France; Colombes, France; Créteil, France (+17 more sites) |
| Start date | 2024-09-19 |
| NCT ID | NCT05952674 |
| Official listing | https://clinicaltrials.gov/study/NCT05952674 |