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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
On a stable drug regimen of psychotropic medication for at least 6 weeks at the time of entry into the study
Patients diagnosed with 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 6
Awards & highlights
Study Summary
This trial is testing a new treatment, MST, for bipolar depression, to see if it is effective and has fewer side effects than ECT.
Who is the study for?
This trial is for adults aged 22-85 with Bipolar Depression or Treatment Resistant Depression who are in good health and not pregnant. Participants must be on a stable medication regimen for at least 6 weeks, able to consent, use effective contraception, and have no history of seizures or severe psychiatric conditions like psychosis.Check my eligibility
What is being tested?
The study compares Magnetic Seizure Therapy (MST) with Electroconvulsive Therapy (ECT) to see which is more effective for treating Bipolar Depression and Treatment Resistant Depression. It also examines the side effects associated with each treatment method.See study design
What are the potential side effects?
Potential side effects may include confusion, memory loss, physical discomfort from the procedure itself, headaches, muscle soreness after treatment, nausea or other anesthesia-related reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been on the same mental health medication for at least 6 weeks.
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I have been diagnosed with Bipolar I or II, or have treatment-resistant depression.
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I am between 22 and 85 years old.
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I have severe depression that hasn't improved with treatment.
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I have been diagnosed with Bipolar I or II and need quick treatment due to the severity of my condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants who go into remission
Secondary outcome measures
Change in cognitive impairment as measured by the Montreal Cognitive Assessment (MoCA)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: magnetic seizure therapy (MST)Experimental Treatment1 Intervention
Group II: electroconvulsive therapy (ECT)Active Control1 Intervention
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Who is running the clinical trial?
Edison LeungLead Sponsor
The University of Texas Health Science Center, HoustonLead Sponsor
914 Previous Clinical Trials
324,312 Total Patients Enrolled
9 Trials studying Bipolar Disorder
693 Patients Enrolled for Bipolar Disorder
Salih Selek, MDPrincipal Investigator - The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
1 Previous Clinical Trials
10 Total Patients Enrolled
1 Trials studying Bipolar Disorder
10 Patients Enrolled for Bipolar Disorder
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have dementia or any illness that affects my brain function.I have a history of epilepsy or seizures that doctors couldn't explain.I have had a brain condition that took up space inside my skull.You have a medical device inside you that is controlled by your body's signals.You have a history of a serious personality disorder.I am a man who can father children and will use contraception.I have a brain condition caused by blood flow issues, injury, infection, or metabolism.You have trouble sleeping or drink a lot of alcohol.If you are a woman who can have children, you need to use a very effective form of birth control for at least 1 month before the study starts and continue using it during the study and for one week after it ends. Please note that while electroconvulsive therapy (ECT) is safe for pregnant women with depression, the effects of transcranial magnetic stimulation (TMS) on a fetus are still unknown.I don't have any health conditions that make anesthesia risky for me.I have been on the same mental health medication for at least 6 weeks.You are at risk of hurting yourself.I have been diagnosed with bipolar depression that includes psychosis.My gender or ethnicity does not limit my participation.You do not live in the United States.I have been on the same mental health medication for at least 6 weeks.Your body mass index (BMI) is higher than 60.You currently have a substance use problem that is not under control, except for nicotine or caffeine.You have an illness that doctors expect will make you live for less than 12 months.I have been diagnosed with Bipolar I or II, or have treatment-resistant depression.I am between 22 and 85 years old.I am not taking antiepileptic or benzodiazepine medications.I have severe depression that hasn't improved with treatment.People of any race and backgroundI have been diagnosed with Bipolar I or II and need quick treatment due to the severity of my condition.
Research Study Groups:
This trial has the following groups:- Group 1: magnetic seizure therapy (MST)
- Group 2: electroconvulsive therapy (ECT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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