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New treatment option for Treatment Resistant Depression (TRD)
Official title Treatment Resistant Depression and Vagus Nerve Stimulation
ClinicalTrials.gov ID: NCT05952674
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- At least one of the following criteria:
You likely can't join if
- Know pregnancy or breastfeeding
- Schizophrenia, schizoaffective disorder or persistent delusional disorder (DSM-5)
- Characterized depressive disorder with psychotic characteristics within 3 months before the inclusion (DSM-5)
- Concomitant participation to another treatment research not authorized by the coordinating investigator or the scientific lead. Participation to...
- Patients receiving enforced cares (ASPDT, ASPPI, ASPDRE, etc.)
- Non-affiliation to a social security regimen or any other social protection regimen
See the full eligibility 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/(Es)Ketamine/TMS and criteria A before the start treatment or ECT/(Es)Ketamine/TMS dependency
- Patients who, after the nature of the study has been explained to them, have given written consent
- Know pregnancy or breastfeeding
- Schizophrenia, schizoaffective disorder or persistent delusional disorder (DSM-5)
- Characterized depressive disorder with psychotic characteristics within 3 months before the inclusion (DSM-5)
- Concomitant participation to another treatment research not authorized by the coordinating investigator or the scientific lead. Participation to non-treatment researches is allowed.
- Patients receiving enforced cares (ASPDT, ASPPI, ASPDRE, etc.)
- Non-affiliation to a social security regimen or any other social protection regimen
- Disability, according to the investigator, to understand the study or refusal to sign the study consent form (non-francophone patient, cognitive disorders)
- Anticipated disability to attend all the visits, treatments and measures planned by the protocol: severe personality disorder, severe substance addiction, severe intellectual development disorder. In any of those cases...
- Surgical contraindication to the VNS
- Positive β-HCG (results obtained after the informed consent is signed but before the randomization)
The study team makes the final eligibility decision.
Where it's taking place
- Angers, France, France
- Bordeaux, France, France
- Caen, France, France
- Clermont-Ferrand, France, France
- Colombes, France, France
- Créteil, France, France
- Dijon, France, France
- Grenoble, France, France
- Le Kremlin-Bicêtre, France, France
- Lille, France, France
- Lyon, France, France
- Marseille, France, France
- Nantes, France, France
- Nice, France, France
- Paris, France, France
- Poitiers, France, France
- Rennes, France, France
- Rouen, France, France
- Saint-Etienne, France, France
- Toulouse, France, France
+ 3 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Angers, France, France; Bordeaux, France, France; Caen, France, France; Clermont-Ferrand, France, France; Colombes, France, France; Créteil, France, France and 17 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.