BridgeMD
New treatment option for Major Depressive Disorder
Official title Search for Novel Transcranial Magnetic Stimulation (TMS) Targets for Mental Illness
ClinicalTrials.gov ID: NCT06376734
What this study is testing
- What it's testing
- Participants will receive Transcranial Magnetic Stimulation (TMS) at a random location in the left prefrontal cortex, excluding sites that are potentially unsafe. Extensive behavioral testing will be conducted to determine which behaviors are modulated by stimulating which circuits.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
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
- Age 18-65
- English proficiency sufficient for informed consent, questionnaires/tasks, and treatment
- Primary diagnosis of one of the following: major depressive disorder (MDD), obsessive-compulsive disorder (OCD), generalized anxiety disorder (GAD)...
- ≥20 on the Beck Depression Inventory for patients with MDD
- ≥16 on the Beck Anxiety Inventory for patients with GAD
You likely can't join if
- Active pregnancy as determined by a urine pregnancy test
- Cluster B personality disorders (antisocial personality disorder, borderline personality disorder, histrionic personality disorder, narcissistic...
- PTSD with active, clinically significant symptoms, as determined by clinician
- Diagnosis of Schizoaffective Disorder, Bipolar Type
- Recent (within 4 weeks) or concurrent use of rapid-acting antidepressant agent (ketamine/esketamine/ECT)
- Ferromagnetic metallic implant that would contraindicate receiving TMS or obtaining MRI
See the full eligibility criteria
- Age 18-65
- English proficiency sufficient for informed consent, questionnaires/tasks, and treatment
- Primary diagnosis of one of the following: major depressive disorder (MDD), obsessive-compulsive disorder (OCD), generalized anxiety disorder (GAD), or schizophrenia (determined by focal assessment using the Structured...
- ≥20 on the Beck Depression Inventory for patients with MDD
- ≥16 on the Beck Anxiety Inventory for patients with GAD
- ≥16 on the Yale-Brown Obsessive-Compulsive Scale for patients with OCD
- ≥58 on the Positive and Negative Symptom Scale for patients with schizophrenia
- Stable psychotropic medication regimen, or remain medication free, for 4 weeks prior to treatment (Medication changes during study enrollment period will be tracked for post hoc analysis).
- Primary clinician (e.g. psychiatrist, therapist, psychologist, APRN, PA, etc.) responsible for psychiatric care before, during, and after the trial
- Active pregnancy as determined by a urine pregnancy test
- Cluster B personality disorders (antisocial personality disorder, borderline personality disorder, histrionic personality disorder, narcissistic personality disorder)
- PTSD with active, clinically significant symptoms, as determined by clinician
- Diagnosis of Schizoaffective Disorder, Bipolar Type
- Recent (within 4 weeks) or concurrent use of rapid-acting antidepressant agent (ketamine/esketamine/ECT)
- Ferromagnetic metallic implant that would contraindicate receiving TMS or obtaining MRI
- Any other TMS or MRI safety concerns identified by the clinician
- Receiving or planning to receive other TMS treatments during course of participation
- History of:
- Neurosurgical intervention for mental illness
- Moderate to severe autism spectrum disorder
- Intellectual disability
- Severe cognitive impairment
- Significant neurological illness (e.g., dementia, Parkinson's, Huntington's, brain tumor, seizure disorder, subdural hematoma, multiple sclerosis)
- Untreated or insufficiently treated endocrine disorder
- Eating disorders
- Treatment with investigational drug or intervention during the study period
- Current evidence of:
- Mania or hypomania
- Active suicidal ideation or a suicide attempt within the past year
- Contraindications to either TMS or MRI (e.g., metallic implants, etc.).
- Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal
- Significantly increased seizure risk as determined by a clinician
- For participants with schizophrenia:
- Evidence of impaired capacity to consent, e.g. impaired insight into illness, as deemed by a licensed psychiatrist or psychologist on the study team
- Hospitalization with psychosis in the past 6 months
- Positive urine drug screen for illicit substances
- Existing tinnitus (ringing in the ears)
- Any other condition deemed by the PI to interfere with the study or increase risk to the participant
The study team makes the final eligibility decision.
Where it's taking place
- Sunnyvale, California, United States
- Boston, Massachusetts, United States
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 Sunnyvale, California, United States; Boston, Massachusetts, United States. 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.