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

Must not have

Diagnosed with the following conditions (current unless otherwise stated): Any other current primary mood, anxiety, or psychotic disorder, Depression secondary to a general medical condition, or substance-induced, Psychotic disorder (lifetime), including schizoaffective disorder, or major depression with psychotic features in the current episode, Eating disorder (current or within the past year), Obsessive compulsive disorder (current or within the past year), Post-traumatic stress disorder (current or within the past year), ADHD (currently being treated), Subjects meeting criteria of any psychiatric illness based upon DSM-5, which in the judgment of the Investigator, may hinder the subjects in completing the procedures required by the study protocol, Actively suicidal, Increased risk of complications from seizure, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or currently taking medication at a dose that significantly alters seizure threshold, as determined by the investigators.

Subjects with any of the following treatment histories: Failure to respond to ECT treatment (i.e., consistent with ATHF confidence level 3 or higher) in this or any previous episode, Lifetime history of treatment with Deep Brain Stimulation or Vagus Nerve Stimulation, Use of any investigational drug or device within 4 weeks of the screening, MRI contraindications (any metal in the body, with the exception of dental fillings, claustrophobia, etc.), Current visual, auditory, or motor impairment that compromises ability to complete evaluations, Positive HIV test, NIMH employees and staff and their immediate family members will be excluded from the study per NIMH policy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up ongoing

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a current or recent psychiatric condition or am at risk of seizures.

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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.

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I do not have a serious brain condition or a low score on a mental status exam.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ ongoing

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~ongoing

This trial's timeline: 3 weeks for screening, Varies for treatment, and ongoing for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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...