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Behavioural Intervention

TEST for Major Depression

N/A

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

Agreement to remain on the same daily dose of psychiatric medication from the start of the baseline assessment through the completion of the final treatment

Male or female, ages 25 through 64 years

Must not have

History of intracranial surgery, cranial metal implants, presence of devices affected by MRI, or head trauma associated with a brain imaging study

Inability to comprehend the study or pass the Evaluation to Sign A Consent Form test

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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

Summary

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

Who is the study for?

Adults aged 25-64 with major depression not improved by standard treatments, including medication or rTMS. They must be stable on current psychiatric medications for at least 4 weeks before and during the trial, agree to use effective contraception if applicable, and not have a history of substance abuse in the past year or certain medical conditions that could interfere with the study.

What is being tested?

The TEST procedure is being studied as an alternative to ECT for treatment-resistant depression. It involves less electricity than traditional ECT and aims to reduce side effects like memory loss. Participants will undergo MRI scans, interviews, questionnaires, blood tests, and brain function assessments over several phases lasting up to 42 weeks.

What are the potential side effects?

Possible side effects may include discomfort from electrodes placed on the head, reactions to general anesthesia used during TEST sessions (if optional ECT is chosen), changes in mood or mental state due to treatment adjustments, and typical risks associated with MRI scans.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I agree to not change my psychiatric medication dose during the study.

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I am between 25 and 64 years old.

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My depression score is severe according to the MADRS.

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My mania symptoms are mild, based on a specific test score.

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I have not changed or added any psychiatric medications for at least 6 weeks.

Exclusion Criteria

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

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I have had brain surgery, metal implants in my head, devices not compatible with MRI, or significant head trauma.

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I understand the study and can pass the consent form test.

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I have had seizures, but only those caused by electroconvulsive therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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

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

Treatment Details

Study Objectives

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

Primary study objectives

Hopkins Verbal Learning Test-Revised (HVLT-R)

change in EEG waveforms from pretreatment session baseline to end of treatment session

Secondary study objectives

Mental Depression

Symptoms of Major Depressive Disorder Scale (SMDDS).

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Transcranial Electric Stimulation Therapy (TEST)Experimental Treatment3 Interventions

TEST involves bifrontal electrical brain stimulation at a dose below the seizure threshold, applied in the same manner as standard electroconvulsive therapy (ECT), with scalp electrodes, under anesthesia, using a standard ECT device (modified or unmodified) that can deliver a range of doses below seizure threshold.

Group II: Sham TESTPlacebo Group1 Intervention

Anesthesia alone

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Thymatron System IV

2002

Completed Phase 2

~20

0 / 8Eligibility criteria met