ECT device set to stimularte at a dose estimated to be below seizure threshold for Bipolar Disorder

National Institutes of Health Clinical Center, Bethesda, MD
Bipolar Disorder+3 More ConditionsECT device set to stimularte at a dose estimated to be below seizure threshold - Device
Eligibility
25 - 64
All Sexes
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Study Summary

This trial is studying a treatment called TEST for people with major depression that has not been relieved by current treatments.

Eligible Conditions
  • Bipolar Disorder
  • Major Depression
  • Depression

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: Baseline, End of Phase II (approximately 2 weeks) and end of Phase III (4-13 weeks)and at 2 and 4 weeks post treatment course

Week 13
Hopkins Verbal Learning Test-Revised (HVLT-R)
Month 5
Mental Depression
Month 5
Symptoms of Major Depressive Disorder Scale (SMDDS).
every treatment throughout course (approximately 3x weekly)
change in EEG waveforms from pretreatment session baseline to end of treatment session

Trial Safety

Phase-Based Safety

1 of 3

Trial Design

2 Treatment Groups

Transcranial Electric Stimulation Therapy (TEST)
1 of 2
Sham TEST
1 of 2

Experimental Treatment

Non-Treatment Group

35 Total Participants · 2 Treatment Groups

Primary Treatment: ECT device set to stimularte at a dose estimated to be below seizure threshold · Has Placebo Group · N/A

Transcranial Electric Stimulation Therapy (TEST)Experimental Group · 4 Interventions: Thymatron System IV, Magnetic Resonance Imaging Scanner, MagPro TMS Stimulator and coil, ECT device set to stimularte at a dose estimated to be below seizure threshold · Intervention Types: Device, Device, Device, Device
Sham TESTShamComparator Group · 2 Interventions: Sham, ECT device without stimulation · Intervention Types: Other, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Thymatron System IV
2002
Completed Phase 2
~20

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, end of phase ii (approximately 2 weeks) and end of phase iii (4-13 weeks)and at 2 and 4 weeks post treatment course

Who is running the clinical trial?

National Institute of Mental Health (NIMH)Lead Sponsor
2,619 Previous Clinical Trials
1,983,026 Total Patients Enrolled
142 Trials studying Bipolar Disorder
63,347 Patients Enrolled for Bipolar Disorder
Sarah H Lisanby, M.D.Principal InvestigatorNational Institute of Mental Health (NIMH)
5 Previous Clinical Trials
419 Total Patients Enrolled

Eligibility Criteria

Age 25 - 64 · All Participants · 0 Total Inclusion Criteria

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Frequently Asked Questions

May I join this medical research initiative?

"Eligible candidates have been diagnosed with manic disorder and are between 25 to 64 years old. This medical trial is in need of 35 participants." - Anonymous Online Contributor

Unverified Answer

Is there still availability to join this research experiment?

"Yes, the information on clinicialtrials.gov indicates that this trial is actively recruiting patients. The research was initially posted on October 6th 2022 and last updated September 30th of the same year. 35 participants need to be recruited from a single medical centre." - Anonymous Online Contributor

Unverified Answer

Does this trial include elderly participants?

"This trial is open to applicants aged 25-64. For those younger and older, there are 414 trials available for minors and 1497 clinical studies designed specifically with seniors in mind." - Anonymous Online Contributor

Unverified Answer

How many participants are joining this research endeavor?

"Indeed, according to the clinicaltrials.gov website, this study is still in need of participants. First posted on October 6th 2022 and edited most recently on September 30th 2022, it seeks 35 individuals from a single medical facility." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.