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New treatment option for Bipolar Disorder
Official title Magnetic Seizure Therapy in Bipolar Depression (MST-BpD) and Treatment Resistant Depression (MST-TRD)
ClinicalTrials.gov ID: NCT04080778
What this study is testing
- What it's testing
- The purpose of this study is to compare the efficacy and side effects magnetic seizure therapy (MST) and electroconvulsive therapy (ECT) in Bipolar Depression (MST-BpD) and Treatment Resistant Depression (MST-TRD).
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 85
You may be able to join if
- The condition under study: Patients who are diagnosed by Bipolar I or II, current episode depressed according to the ICD-10 diagnostic criteria...
- Both males and females any race and ethnic group.
- Age range between 22-85 years old.
- Ability to provide informed consent or assent.
- Ability to adhere to the study procedures.
You likely can't join if
- Condition or diagnosis that precludes participation, including: Patients who have an implanted device that is activated or controlled in any way by...
- Known allergic reactions to components of anaesthetic or induction agents including succinylcholine, metohexitol, ketamine, propofol, ketorolac.
- Participation in another drug, device, or biologics trial within the preceding 30 days
- Disallowed concomitant medications: antiepileptics and benzodiazepines as they are against seizure therapies, short or mid acting benzodiazepines...
See the full eligibility criteria
- The condition under study: Patients who are diagnosed by Bipolar I or II, current episode depressed according to the ICD-10 diagnostic criteria (F31.3, F31.4, F31.5, F31.81) or treatment resistant depression defined...
- Both males and females any race and ethnic group.
- Age range between 22-85 years old.
- Ability to provide informed consent or assent.
- Ability to adhere to the study procedures.
- 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 and for an additional one week after the...
- For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner.
- Has sufficient English in completing self-rated scales.
- Good general health evidenced by obtained medical clearance before the procedures from another provider.
- On a stable drug regimen of psychotropic medication for at least 6 weeks at the time of entry into the study. Medication changes can be made during patient's study participation but would be limited to the clinical...
- Condition or diagnosis that precludes participation, including: Patients who have an implanted device that is activated or controlled in any way by physiological signals (examples: pacemakers, implantable cardioverter...
- Known allergic reactions to components of anaesthetic or induction agents including succinylcholine, metohexitol, ketamine, propofol, ketorolac.
- Participation in another drug, device, or biologics trial within the preceding 30 days
- Disallowed concomitant medications: antiepileptics and benzodiazepines as they are against seizure therapies, short or mid acting benzodiazepines such as alprazolam, temazepam, midazolam, lorazepam will be allowed but...
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, 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, 22 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, 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.