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MST for Bipolar Disorder

N/A
Recruiting
Led By Edison Leung, MD, PhD
Research Sponsored by Edison Leung
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner
On a stable drug regimen of psychotropic medication for at least 6 weeks at the time of entry into the study
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 below
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I am a man who can father children and will use contraception.
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I have been on the same mental health medication for at least 6 weeks.
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My gender or ethnicity does not limit my participation.
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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 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

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

Find a Location

Who is running the clinical trial?

Edison LeungLead Sponsor
The University of Texas Health Science Center, HoustonLead Sponsor
902 Previous Clinical Trials
320,844 Total Patients Enrolled
9 Trials studying Bipolar Disorder
693 Patients Enrolled for Bipolar Disorder
Edison Leung, MD, PhDPrincipal InvestigatorThe University of Texas Health Science Center, Houston

Media Library

ECT (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04080778 — N/A
Bipolar Disorder Research Study Groups: electroconvulsive therapy (ECT), magnetic seizure therapy (MST)
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants can the clinical trial accommodate?

"Affirmative. Clinicaltrials.gov lists this trial as currently being open for enrolment, having first been published on March 1st 2023 and most recently updated October 31st 2022. The study is looking to recruit 60 patients from one location."

Answered by AI

Are there age restrictions within this research program?

"Patients aged over 22 and under 85 are eligible to be enrolled in this clinical investigation."

Answered by AI

Is recruitment still possible for this research program?

"The data hosted on clinicaltrials.gov suggests that this medical research project is currently in the process of recruiting participants. It was initially posted on March 1st 2023, and has since been updated as recent as October 31st 2022."

Answered by AI

Is it feasible for me to participate in this experiment?

"To qualify for the trial, applicants must have manic disorder and be between 22 to 85 years of age. The research team is aiming to recruit up to 60 participants."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
The University of Texas Health Science Center at Houston
What portion of applicants met pre-screening criteria?
Met criteria
~40 spots leftby Oct 2024