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iLAST for Depression
Phase 1
Recruiting
Led By Sarah H Lisanby, M.D.
Research Sponsored by National Institute of Mental Health (NIMH)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up ongoing
Awards & highlights
Study Summary
This trial is testing a new, safer way to give electroconvulsive therapy (ECT) called iLAST. ECT is used to treat people with severe depression and can cause memory loss as a side effect. The trial will last up to 20 weeks, during which participants will have various tests to see if iLAST is safe and feasible.
Who is the study for?
Adults aged 22-70 with major depressive disorder eligible for ECT can join this trial. They must understand the study, consent to it, follow a strict treatment schedule, and not change their psychiatric medications during Phase II. Women of childbearing age should use birth control and have a negative pregnancy test.Check my eligibility
What is being tested?
The iLAST method is being tested as an alternative to traditional ECT for treating severe depression. It involves MRI scans, brain activity recordings (MEG), electrical stimulation (TMS), nerve function tests (SEP), and interviews about mood and side effects over three phases lasting up to 20 weeks.See study design
What are the potential side effects?
Potential side effects may include memory loss similar to standard ECT, discomfort or risks from anesthesia during seizures induced by iLAST sessions, headaches or scalp discomfort from TMS, and general discomfort from participating in various testing procedures like MRIs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ ongoing
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~ongoing
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Successful seizure induction as measured by topographical EEG and motor manifestations, vital signs, ECG, subjective side effect scale, and adverse events/significant adverse events
Secondary outcome measures
Neurocognitive battery known to be sensitive to the cognitive effects of ECT, with alternative versions to avoid practice effects; and, Amplitude-titrated seizure threshold (STa), measured electrical motor threshold (MT), and simulated MT derive...
Trial Design
3Treatment groups
Experimental Treatment
Group I: TMSExperimental Treatment1 Intervention
Transcranial magnetic stimulation measurements of cortical excitability pre and post ECT treatment
Group II: MRIExperimental Treatment1 Intervention
Structural and functional neuroimaging pre and post ECT treatment
Group III: ECTExperimental Treatment1 Intervention
ECT treatment, Within subject cross-over
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MRI
2009
Completed Phase 2
~1370
Find a Location
Who is running the clinical trial?
National Institute of Mental Health (NIMH)Lead Sponsor
2,807 Previous Clinical Trials
2,665,646 Total Patients Enrolled
Sarah H Lisanby, M.D.Principal InvestigatorNational Institute of Mental Health (NIMH)
5 Previous Clinical Trials
434 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with major depressive disorder using a specific interview called the structured clinical interview for the DSM-5.I am eligible for or currently receiving maintenance electroconvulsive therapy (ECT).My serious health conditions are well-managed and won't affect my study participation.I am willing and able to follow the treatment plan and study requirements.I haven't changed my mental health medications for 4 weeks and won't change them during the study.You have had issues with drugs or alcohol in the past 6 months, except for nicotine and caffeine.I have a current or recent psychiatric condition or am at risk of seizures.Criterion: You have been treated with certain therapies in the past, have used an experimental drug or device recently, have metal in your body, have certain impairments, or are an NIMH employee or family member.I have no history of seizures, brain surgery, or metal implants that could interfere with brain scans.I do not have a serious brain condition or a low score on a mental status exam.I am between 22 and 70 years old.
Research Study Groups:
This trial has the following groups:- Group 1: TMS
- Group 2: ECT
- Group 3: MRI
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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