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New treatment option for Treatment-Resistant Depression
Official title Focused Ultrasound Neuromodulation in Patients With Treatment-Resistant Depression
ClinicalTrials.gov ID: NCT07094789
What this study is testing
- What it's testing
- The goal of this clinical trial is to evaluate the safety and initial effectiveness of Magnetic Resonance-guided focused ultrasound neuromodulation using the Next Generation Dome Helmet (NGDH) device in patients with treatment-resistant depression. This is a prospective, single-arm, non-randomized study.
- 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 to 65
You may be able to join if
- Deemed to have the capacity to provide informed consent.
- Aged between 18 and 65 years.
- Diagnosis of major depressive disorder (MDD) according to DSM-5 criteria.
- Total score \>20 on the Hamilton Depression Rating Scale (HAMD-17).
- On a stable regimen of psychiatric medications for at least 30 days prior to enrollment.
You likely can't join if
- Pregnant or intending to become pregnant during the study period.
- Diagnosis of a substance use disorder (excluding cannabis or nicotine) of moderate severity or greater, or when the substance is the primary focus of...
- Known active seizure disorder, significant head injury with an imaging-verified lesion
- Unstable medical illness.
- Not eligible for 3-Tesla MRI (i.e. MRI-incompatible pacemaker)
- Inability to reliably attend required screening, treatment, or follow-up appointments.
See the full eligibility criteria
- Deemed to have the capacity to provide informed consent.
- Aged between 18 and 65 years.
- Diagnosis of major depressive disorder (MDD) according to DSM-5 criteria.
- Total score \>20 on the Hamilton Depression Rating Scale (HAMD-17).
- On a stable regimen of psychiatric medications for at least 30 days prior to enrollment.
- Documented previous trial of at least two first-line antidepressant agents at adequate dose and duration, as assessed by two psychiatrists.
- Documented previous trial of cognitive behavioral therapy (CBT) or psychotherapy for MDD, sustained for at least 6 weeks.
- Pregnant or intending to become pregnant during the study period.
- Diagnosis of a substance use disorder (excluding cannabis or nicotine) of moderate severity or greater, or when the substance is the primary focus of treatment, based on DSM-5 criteria.
- Known active seizure disorder, significant head injury with an imaging-verified lesion
- Unstable medical illness.
- Not eligible for 3-Tesla MRI (i.e. MRI-incompatible pacemaker)
- Inability to reliably attend required screening, treatment, or follow-up appointments.
- Severe claustrophobia, as identified by the participant, that would prevent completion of MRI procedures.
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
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 Toronto, Ontario, Canada. 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.