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Intensive TMS for Bipolar Disorder
Study Summary
This trial will test if high-dose, spaced out theta-burst transcranial magnetic stimulation (rTMS) can help reduce symptoms of bipolar depression better than a sham treatment. It will enroll patients who are 18-70 years old, have failed two prior treatments, and still have depressive symptoms.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You have any implants, medical conditions, or reasons that would make it unsafe for you to have TMS or MRI.You have been diagnosed with bipolar depression according to the DSM 5 criteria.You have a mental illness that causes you to have hallucinations or delusions, or you currently experience these symptoms. However, if your psychiatrist believes that your personality disorder would not interfere with your ability to participate in the study, it may not be a reason for exclusion.If you have had more than 4 mood swings in the past year, you will not be able to participate in the study because you have a higher risk of experiencing manic episodes.You can be right-handed or left-handed.You do not have depression as your main health problem.You have depression that has not improved with at least two different antidepressant treatments, even when following specific guidelines for measuring improvement.
- Group 1: Active Transcranial Magnetic Stimulation
- Group 2: Sham Transcranial Magnetic Stimulation
- 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.
Frequently Asked Questions
Is the requisite age for entry into this research 18 or older?
"This clinical trial has established specific age boundaries of 18 to 70 years old for eligible applicants. For those younger than 18, 205 studies may be available; conversely, 1030 trials are accessible to individuals over 65."
How many participants have been enrolled in this investigation?
"Affirmative. According to clinicaltrials.gov, this medical trial is currently accepting participants and was first publicized on March 1st 2022 with the latest update occurring two weeks later on the 17th of that same month. 32 people need to be enrolled from a single site for completion of the study's objectives."
Does this research experiment currently have any vacancies for participants?
"Yes, clinicaltrials.gov indicates that this medical research is currently recruiting participants. This trial was initially launched on March 1st 2022 and recently amended on the 17th of the same month. 32 individuals are needed from a single location to complete this study."
What are the criteria for inclusion in this medical study?
"For this trial, 32 individuals between 18 and 70 who have melancholia are being sought. Those wishing to participate must meet the following criteria: a DSM 5 diagnosis of bipolar disorder type I or II, right- or left-handedness, any gender identity, treatment resistant depression as defined by ATHF standards with at least two prior unsuccessful antidepressant trials, current use of one mood stabilizer medication, competency in providing informed consent for participation in the study and scoring 20+ on Montgomery Asberg Depression Rating Scale (MADRS)."
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