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MST for Bipolar Disorder

N/A
Recruiting
Led By Salih Selek, MD
Research Sponsored by Edison Leung
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
Must not have
Degenerative diseases of the central nervous system such as dementia or medical illness affecting brain function
Patients with a history of epilepsy or unexplained seizures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 6
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have dementia or any illness that affects my brain function.
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I have a history of epilepsy or seizures that doctors couldn't explain.
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I have had a brain condition that took up space inside my skull.
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I have a brain condition caused by blood flow issues, injury, infection, or metabolism.
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I don't have any health conditions that make anesthesia risky for me.
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I have been diagnosed with bipolar depression that includes psychosis.
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I am not taking antiepileptic or benzodiazepine medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants who go into remission
Secondary study objectives
Change in cognitive impairment as measured by the Montreal Cognitive Assessment (MoCA)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

Edison LeungLead Sponsor
The University of Texas Health Science Center, HoustonLead Sponsor
949 Previous Clinical Trials
344,965 Total Patients Enrolled
10 Trials studying Bipolar Disorder
1,693 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

Media Library

ECT (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04080778 — N/A
Bipolar Disorder Research Study Groups: magnetic seizure therapy (MST), electroconvulsive therapy (ECT)
Bipolar Disorder Clinical Trial 2023: ECT Highlights & Side Effects. Trial Name: NCT04080778 — N/A
ECT (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04080778 — N/A
~40 spots leftby Dec 2025
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