BridgeMD
New treatment option for Bipolar Depression
Official title Deep Brain Stimulation of Treatment-Resistant Bipolar Depression
ClinicalTrials.gov ID: NCT06599099
What this study is testing
- What it's testing
- This study is only enrolling at Baylor College of Medicine. The other research locations listed serve to support data analysis only.
- Time commitment: about 20 months
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 64
You may be able to join if
- Males and females ages 22-64, inclusive
- Diagnosis: Bipolar I disorder confirmed by SCID-5, currently in a major depressive episode (MDE).
- Symptom Severity: MADRS score of ≥27 at Screening and pre-operative baseline visit. CGI-S \> 4 and YMRS \<12 at these visits.
- Failure to respond or maintain a response to a minimum of four evidence-based interventions for bipolar depression in the patient's lifetime...
- Initial mood episode occurred before the age of 40 - to minimize risk of enrolling patients with so atypical onset of initial mania/depression.
You likely can't join if
- Lifetime history of a psychotic disorder (e.g., schizophrenia, schizoaffective disorder, and other psychotic disorders), or any history of psychotic...
- Currently meets criteria for a manic or hypomanic episode or rapid cycling (4 or more mood episodes in the previous 12 months).
- Any psychiatric disorder which is the primary focus of treatment within the past 12 months (with bipolar disorder as the secondary focus of...
- Alcohol/substance use disorder, moderate or severe, within the previous 12 months [excluding nicotine].
- Intellectual disability or neurocognitive disorder.
- Current major and/or unstable medical conditions. e.g., liver insufficiency, kidney insufficiency, cardiovascular problems [unstable arrhythmias...
See the full eligibility criteria
- Males and females ages 22-64, inclusive
- Diagnosis: Bipolar I disorder confirmed by SCID-5, currently in a major depressive episode (MDE).
- Symptom Severity: MADRS score of ≥27 at Screening and pre-operative baseline visit. CGI-S \> 4 and YMRS \<12 at these visits.
- Failure to respond or maintain a response to a minimum of four evidence-based interventions for bipolar depression in the patient's lifetime, including at least two FDA-approved medications (olanzapine/fluoxetine...
- Initial mood episode occurred before the age of 40 - to minimize risk of enrolling patients with so atypical onset of initial mania/depression.
- Must be on a stable dose of psychotropic medications for a minimum of four weeks prior to surgery.
- Minimum score on the Montreal Cognitive Assessment (MoCA).
- Able and willing to give informed consent and sign Treatment Contract that includes identification of a reliable informant.
- Lifetime history of a psychotic disorder (e.g., schizophrenia, schizoaffective disorder, and other psychotic disorders), or any history of psychotic symptoms when not in a bipolar mood episode.
- Currently meets criteria for a manic or hypomanic episode or rapid cycling (4 or more mood episodes in the previous 12 months).
- Any psychiatric disorder which is the primary focus of treatment within the past 12 months (with bipolar disorder as the secondary focus of treatment).
- Alcohol/substance use disorder, moderate or severe, within the previous 12 months [excluding nicotine].
- Intellectual disability or neurocognitive disorder.
- Current major and/or unstable medical conditions. e.g., liver insufficiency, kidney insufficiency, cardiovascular problems [unstable arrhythmias, chronic heart failure, myocardial infarction (MI), cardiac pacemaker]...
- Any medical contraindication to surgery or condition that makes the patient, in the opinion of the surgeon, a poor candidate.
- Female who is pregnant or breastfeeding or has plans to become pregnant in the next 24 months.
- Any contraindication for MRI.
- Patients with a clinically significant personality disorder, including risk for homicidal or aggressive behavior, which in the opinion of the investigator has a major impact on the patient's current psychiatric status...
- Patients at serious and imminent risk of suicide and not suitable for an outpatient study, in the judgment of the investigators.
- Participation in any investigational clinical trial within the preceding 30 days.
- Current implanted stimulation devices including cardiac pacemakers, defibrillators, and neurostimulators [including deep brain and spinal cord stimulators].
- Patients with no regular contact with at least one adult. Patients who are undomiciled are excluded.
- Body mass index (BMI) less than 16 and greater than 40 kg/m2
- Need for diathermy.
- Unable to sign the informed consent for any reason.
- Patients who are not under the care of a psychiatrist at Screening and throughout the duration of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- Houston, Texas, United States
- Seattle, Washington, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 study runs about 20 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; Houston, Texas, United States; Seattle, Washington, 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.