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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

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Hopkins Verbal Learning Test-Revised (HVLT-R)

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

Secondary outcome measures

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 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)Lead Sponsor

2,785 Previous Clinical Trials

2,689,721 Total Patients Enrolled

145 Trials studying Bipolar Disorder

63,550 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

Media Library

Transcranial Electric Stimulation Therapy (TEST) (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05172271 — N/A

Bipolar Disorder Research Study Groups: Sham TEST, Transcranial Electric Stimulation Therapy (TEST)

Bipolar Disorder Clinical Trial 2023: Transcranial Electric Stimulation Therapy (TEST) Highlights & Side Effects. Trial Name: NCT05172271 — N/A

Transcranial Electric Stimulation Therapy (TEST) (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05172271 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI