35 Participants Needed

TEST for Major Depression

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SH
WT
PS
AW
Overseen ByAidan Wade
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: National Institute of Mental Health (NIMH)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

Participants must stay on the same daily dose of their psychiatric medications for at least 6 weeks before starting the trial and throughout the study, unless the investigator advises otherwise. If you need to reduce your medication dosage, it must be done at least 4 weeks before the trial begins.

What data supports the effectiveness of the treatment Transcranial Electric Stimulation Therapy (TEST) for major depression?

Research shows that transcranial direct current stimulation (tDCS), a part of TEST, is a promising non-drug therapy for major depression, with studies indicating it can be effective for acute episodes and potentially beneficial when combined with other treatments.12345

Is transcranial electric stimulation therapy (TEST) safe for humans?

Transcranial electric stimulation, including tDCS and tACS, is generally considered safe for humans, with no serious adverse events reported in over 18,000 sessions. Mild side effects like headaches and skin sensations are possible, but serious issues are rare.678910

How is Transcranial Electric Stimulation Therapy (TEST) different from other treatments for major depression?

Transcranial Electric Stimulation Therapy (TEST), also known as transcranial direct current stimulation (tDCS), is unique because it is a non-invasive brain stimulation technique that modulates brain activity using a low electrical current. Unlike traditional antidepressant medications, it does not involve drugs and can be administered at home under supervision, offering a potential alternative for those who do not respond well to medications.1251112

What is the purpose of this trial?

Background:People with TRD are often helped by electroconvulsive therapy (ECT). But ECT can affect memory and thinking. Researchers want to study a treatment called TEST that uses less electricity.Objective:To study the safety and feasibility of TEST and assess its antidepressant effects.Eligibility:Adults aged 25-64 with major depression that has not been relieved by current treatments.Design:Participants will be admitted to the NIH Clinical Center for 5 18 weeks over 2 3 treatment phases. Their medications may be adjusted.Participants will be interviewed about their depression, side effects, and other treatments they are receiving. They will complete questionnaires. They will give blood and urine samples. Their brain waves and heart rhythm will be recorded. They will take tests of memory, attention, mental functioning, and thinking.Participants will have magnetic resonance imaging (MRI) scans of the head and brain. They will lie on a table that slides in and out of the scanner. Pictures of brain chemicals will also be taken. They may complete tasks during the MRI.Participants will receive TEST and/or sham treatments. They may receive optional ECT. An intravenous catheter will be placed in an arm vein to receive general anesthesia. Two electrodes will be placed on the front of their head. An electric current will be passed from the ECT machine through the electrodes. For sham treatments, they will not receive the electric current. Their breathing, heart rate, brain function, blood pressure, and body movements will be measured.Participants will have 7 follow-up visits over 6 months. Visits can be done via telehealth.Participation will last for up to 42 weeks.

Research Team

WT

William T Regenold, M.D.

Principal Investigator

National Institute of Mental Health (NIMH)

Eligibility Criteria

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.

Inclusion Criteria

Willingness to provide written permission for communication between the Investigator/Research Staff and healthcare provider, and provide emergency contact information
Ability to understand and sign a written informed consent document as determined by the Investigator
For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening
See 10 more

Exclusion Criteria

Being an NIMH employee or an immediate family member of an NIMH employee
I do not have any health issues that would stop me from completing the study.
Expression of recent or current active suicidal ideas and an explicit plan or intent
See 12 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase I

Participants receive TEST or sham treatments, with monitoring of safety and feasibility

2-3 weeks
Approximately 3 visits per week

Treatment Phase II

Continuation of TEST or sham treatments, with further monitoring and assessments

2 weeks
Approximately 3 visits per week

Treatment Phase III

Final phase of TEST or sham treatments, with comprehensive assessments

4-13 weeks
Approximately 3 visits per week

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
7 visits, can be done via telehealth

Treatment Details

Interventions

  • Transcranial Electric Stimulation Therapy (TEST)
Trial Overview 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.
Participant Groups
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

Transcranial Electric Stimulation Therapy (TEST) is already approved in United States, European Union, Canada for the following indications:

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Transcranial Direct Current Stimulation (tDCS) for:
  • Major Depressive Disorder
  • Chronic Pain
  • Stroke Rehabilitation
๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as Transcranial Direct Current Stimulation (tDCS) for:
  • Major Depressive Disorder
  • Chronic Pain
  • Stroke Rehabilitation
  • Schizophrenia
๐Ÿ‡จ๐Ÿ‡ฆ
Approved in Canada as Transcranial Direct Current Stimulation (tDCS) for:
  • Major Depressive Disorder
  • Chronic Pain
  • Stroke Rehabilitation

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Institute of Mental Health (NIMH)

Lead Sponsor

Trials
3,007
Recruited
2,852,000+

Findings from Research

Transcranial direct current stimulation (tDCS) significantly improved depressive symptoms in patients who had not responded to previous pharmacological treatments, with a notable reduction in scores on the Beck Depression Inventory (BDI) and Hamilton Depression Rating Scale (HDRS) after just five days of treatment.
The study found that the effectiveness of tDCS was influenced by prior medication use; specifically, benzodiazepines were linked to poorer outcomes, while dual-reuptake inhibitors showed a positive interaction with tDCS effects.
Interactions between transcranial direct current stimulation (tDCS) and pharmacological interventions in the Major Depressive Episode: findings from a naturalistic study.Brunoni, AR., Ferrucci, R., Bortolomasi, M., et al.[2020]
In a case series of 16 treatment-resistant depression patients, home-administered transcranial direct current stimulation (HA-tDCS) showed clinical benefits, with 5 out of 12 patients responding within 6 weeks and 9 maintaining improvements after 12 weeks of treatment.
HA-tDCS was found to be safe and well-tolerated, with no significant cognitive impairments reported over up to 2 years of treatment, although two patients experienced mild side effects.
A Clinical Case Series of Acute and Maintenance Home Administered Transcranial Direct Current Stimulation in Treatment-Resistant Depression.Le, B., Alonzo, A., Bull, M., et al.[2023]
In the SELECT-TDCS trial, transcranial direct current stimulation (tDCS) was effective in treating major depression, with 52% of participants responding positively during the crossover phase after previously receiving sham treatment.
During the follow-up phase, the average duration of response to tDCS was 11.7 weeks, but patients with treatment-resistant depression had a significantly lower survival rate (10%) compared to non-refractory patients (77%), highlighting the need for optimized continuation protocols to prevent relapse.
The sertraline versus electrical current therapy for treating depression clinical study (select-TDCS): results of the crossover and follow-up phases.Valiengo, L., Benseรฑor, IM., Goulart, AC., et al.[2014]

References

Interactions between transcranial direct current stimulation (tDCS) and pharmacological interventions in the Major Depressive Episode: findings from a naturalistic study. [2020]
A Clinical Case Series of Acute and Maintenance Home Administered Transcranial Direct Current Stimulation in Treatment-Resistant Depression. [2023]
The sertraline versus electrical current therapy for treating depression clinical study (select-TDCS): results of the crossover and follow-up phases. [2014]
Transcranial direct current stimulation in treatment resistant depression: a randomized double-blind, placebo-controlled study. [2022]
Is transcranial direct current stimulation, alone or in combination with antidepressant medications or psychotherapies, effective in treating major depressive disorder? A systematic review and meta-analysis. [2022]
Protocol on transcranial alternating current stimulation for the treatment of major depressive disorder: a randomized controlled trial. [2023]
Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. [2023]
Blinding efficacy and adverse events following repeated transcranial alternating current, direct current, and random noise stimulation. [2022]
Tolerability of Repeated Application of Transcranial Electrical Stimulation with Limited Outputs to Healthy Subjects. [2018]
A double-blind, randomized, sham-controlled study of cranial electrotherapy stimulation as an add-on treatment for tic disorders in children and adolescents. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Transcranial direct current stimulation as a therapeutic tool for the treatment of major depression: insights from past and recent clinical studies. [2009]
The Escitalopram versus Electric Current Therapy for Treating Depression Clinical Study (ELECT-TDCS): rationale and study design of a non-inferiority, triple-arm, placebo-controlled clinical trial. [2015]
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