Bipolar Disorder study: MagVenture MagPro TMS system
Official title Neuromodulation of Mood Switch Circuitry in Bipolar Disorder
ClinicalTrials.gov ID: NCT07680153
What this study is testing
- What it's testing
- The study wants to see if targeted brain stimulation can help shift mood from depressed to stable and improve depression symptoms.
- Who it's for
- Adults with bipolar disorder who are currently depressed.
- What's involved
- Participants will receive two courses of brain stimulation, one real and one sham, while doctors track mood and use brain scans to guide the treatment.
- Time commitment
- The study lasts several weeks, with multiple visits for scans, stimulation sessions, and mood assessments.
- Phase 4: studies an already-approved treatment
You might receive a placebo (an inactive treatment) instead of the study drug, 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 70
You may be able to join if
- Provision of signed and dated informed consent form.
- Adults of all genders aged 18-70 at the time of screening.
- Diagnosis of Bipolar Disorder (by DSM-V criteria)
- Depressive symptoms of at least moderate severity (GRID HDRS-17 score \>= 14 or as determined by expert clinician).
- Not currently taking medications for BD OR on a stable dose of medication for at least 1 month prior to screening and plans to remain off medications...
You likely can't join if
- Imminent risk of suicide.
- Presence of a primary DSM-5 diagnosis other than bipolar disorder (BD-I or BD-II), or a current comorbid psychiatric disorder that, in the opinion of...
- History of seizures or any condition / concurrent medication that could notably lower seizure threshold.
- Met criteria for any significant substance use disorder (by DSM-V criteria) in the 6 months prior to screening.
- History or presence of significant neurological disorder (e.g., traumatic brain injury, stroke, Parkinson's disease or other movement disorder...
- History or presence of significant heart condition (e.g., recent myocardial infarction, congestive heart failure \> stage 2, angina pectoris...
See the full eligibility criteria
- Provision of signed and dated informed consent form.
- Adults of all genders aged 18-70 at the time of screening.
- Diagnosis of Bipolar Disorder (by DSM-V criteria)
- Depressive symptoms of at least moderate severity (GRID HDRS-17 score \>= 14 or as determined by expert clinician).
- Not currently taking medications for BD OR on a stable dose of medication for at least 1 month prior to screening and plans to remain off medications OR on this stable dose for the duration of participation.
- Access to psychiatric care before, during, and after completion of the study.
- For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation.
- Proficiency in English sufficient to complete assessments and follow study procedure instructions.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Imminent risk of suicide.
- Presence of a primary DSM-5 diagnosis other than bipolar disorder (BD-I or BD-II), or a current comorbid psychiatric disorder that, in the opinion of the investigators, would confound outcome assessment or interfere...
- History of seizures or any condition / concurrent medication that could notably lower seizure threshold.
- Met criteria for any significant substance use disorder (by DSM-V criteria) in the 6 months prior to screening.
- History or presence of significant neurological disorder (e.g., traumatic brain injury, stroke, Parkinson's disease or other movement disorder, epilepsy).
- History or presence of significant heart condition (e.g., recent myocardial infarction, congestive heart failure \> stage 2, angina pectoris, bradycardia or tachycardia at the baseline assessment, uncontrolled...
- MRI contraindication, including presence of foreign metal bodies or implants, implanted or conductive objects in or near the head (e.g., stents, deep brain stimulators, vagus nerve stimulators, aneurysm coils, ocular...
- Individuals who are nursing, pregnant, or contemplating pregnancy within the length of study participation.
- Abnormal bloodwork for electrolytes, thyroid, or liver function.
- History or presence of any disorder or medical condition that, in the opinion of the study team, may compromise, interfere, or limit the individual's ability to complete the intervention or study procedures.
The study team makes the final eligibility decision.
Where it is enrolling
- New York, New York, 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, but 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 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at New York, New York, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.