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New treatment option for Treatment Resistant Depression
Official title Translational Biomarkers in Accelerated Neuromodulation for Treatment-resistant Depression
ClinicalTrials.gov ID: NCT05798143
What this study is testing
- What it's testing
- Background: 30-50% of patients with Major Depressive Disorder (MDD) do not respond adequately despite two or more antidepressant treatments with proper dosage and timing of administration, configuring a condition of Treatment-Resistant Depression (TRD). Repetitive Transcranial Magnetic Stimulation (rTMS) is a neuromodulation technique that uses a magnetic field to stimulate focal cortical brain regions and it has been approved by the FDA for the treatment of TRD.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Current diagnosis of Major Depressive Disorder (MDD), based on the Diagnostic and Statistical Manual of Mental Disorder - Fifth Edition (DSM-5);
- people without clinical response to at least two antidepressant treatments administered at adequate dosage and duration during the current episode;
- Stable psychopharmacological treatment for at least one month.
You likely can't join if
- Co-morbidity with organic diseases that could interfere with magnetic stimulation safety (epilepsy, brain lesions or diseases, previous neurosurgery...
- Diagnosis of Substance or Alcohol Use Disorder (DSM-5) in the past 6 months;
- Substances of abuse or alcohol acute intoxication or abstinence;
- Co-morbidity with significant organic or neurological diseases;
- Personal or familiar (1st degree relatives) medical history of seizures;
- Significant eye diseases that could interfere with ERG execution;
See the full eligibility criteria
- Current diagnosis of Major Depressive Disorder (MDD), based on the Diagnostic and Statistical Manual of Mental Disorder - Fifth Edition (DSM-5);
- people without clinical response to at least two antidepressant treatments administered at adequate dosage and duration during the current episode;
- Stable psychopharmacological treatment for at least one month.
- Co-morbidity with organic diseases that could interfere with magnetic stimulation safety (epilepsy, brain lesions or diseases, previous neurosurgery, metal grafts, cardiac devices) based on applied procedure guidelines;
- Diagnosis of Substance or Alcohol Use Disorder (DSM-5) in the past 6 months;
- Substances of abuse or alcohol acute intoxication or abstinence;
- Co-morbidity with significant organic or neurological diseases;
- Personal or familiar (1st degree relatives) medical history of seizures;
- Significant eye diseases that could interfere with ERG execution;
- For female patients: Pregnancy/breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Chieti, Italy
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 to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chieti, Italy. 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.