35 Participants Needed

TEST for Major Depression

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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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment, Transcranial Electric Stimulation Therapy (TEST), for individuals with major depression unresponsive to current treatments. TEST resembles electroconvulsive therapy (ECT) but uses less electricity, potentially resulting in fewer side effects like memory issues. The researchers aim to determine if TEST is safe and effective in reducing depression. This trial may suit adults who have not found success with various depression treatments. Participants will receive either the TEST treatment or a placebo and will be closely monitored throughout the study. As an unphased trial, this study offers a unique opportunity to contribute to pioneering research that could lead to new treatment options for depression.

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 prior data suggests that Transcranial Electric Stimulation Therapy (TEST) is safe for treating major depression?

Research shows that treatments like Transcranial Electric Stimulation Therapy (TEST), including transcranial direct current stimulation (tDCS) and transcranial alternating current stimulation (tACS), are usually well-tolerated. Studies indicate that these treatments do not cause serious side effects, with the most common issues being minor skin problems. One review found that a similar treatment used at home for 10 weeks was safe and well-accepted. Overall, existing research suggests that TEST might be safe, but this study aims to learn more about its specific effects and safety.12345

Why are researchers excited about this trial?

Transcranial Electric Stimulation Therapy (TEST) is unique because it offers a new approach to treating major depression by using electrical brain stimulation at levels below the seizure threshold. Unlike traditional electroconvulsive therapy (ECT), which induces seizures to achieve its effects, TEST delivers a gentler stimulation without causing seizures. This method could potentially result in fewer side effects and a quicker recovery time, making it an exciting development for improving patient comfort and safety in depression treatment.

What evidence suggests that TEST might be an effective treatment for major depression?

Research has shown that Transcranial Electric Stimulation Therapy (TEST), which participants in this trial may receive, may help reduce depression symptoms. Similar treatments, such as transcranial direct current stimulation (tDCS), have significantly improved depression symptoms. For instance, one study reported that patients experienced noticeable relief from their symptoms. Another study found that a 10-week course of active tDCS led to clear mood improvements. Although TEST differs from tDCS, these findings suggest that using electrical stimulation to treat depression holds promise.34678

Who Is on the Research Team?

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William T Regenold, M.D.

Principal Investigator

National Institute of Mental Health (NIMH)

Are You a Good Fit for This Trial?

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
Meeting structured clinical interview for the DSM 5 (SCID) criteria for major depressive disorder, bipolar I disorder, or bipolar II disorder
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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Transcranial Electric Stimulation Therapy (TEST)Experimental Treatment3 Interventions
Group II: Sham TESTPlacebo Group1 Intervention

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

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Approved in United States as Transcranial Direct Current Stimulation (tDCS) for:
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Approved in European Union as Transcranial Direct Current Stimulation (tDCS) for:
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Approved in Canada as Transcranial Direct Current Stimulation (tDCS) for:

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+

Published Research Related to This Trial

Cranial electrotherapy stimulation (CES) was tested as an add-on treatment for tic disorders (TD) in a study involving 62 patients aged 6-17 years, showing a reduction in tic severity after 4 weeks of treatment.
While both active CES and sham CES groups experienced improvements in tic severity, the difference was not statistically significant, suggesting that the observed benefits may be largely due to a placebo effect.
A double-blind, randomized, sham-controlled study of cranial electrotherapy stimulation as an add-on treatment for tic disorders in children and adolescents.Wu, WJ., Wang, Y., Cai, M., et al.[2021]
Transcranial direct current stimulation (tDCS) significantly reduced depression scores compared to sham treatment, with the most effective results seen when tDCS was combined with medication, particularly selective serotonin re-uptake inhibitors (SSRIs).
The study included 12 randomized, sham-controlled trials with 251 participants receiving active tDCS and 204 receiving sham, showing that while tDCS alone or combined with psychotherapy did not significantly improve outcomes, the combination with medication led to a higher response rate and a greater reduction in depression scores.
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.Wang, J., Luo, H., Schรผlke, R., et al.[2022]
The study evaluates the efficacy and safety of transcranial alternating current stimulation (tACS) in treating major depressive disorder (MDD) over 8 weeks, involving 92 drug-naive patients who received either active or sham stimulation.
The primary outcome is the remission rate measured by the Hamilton depression rating scale, with the study aiming to demonstrate that tACS can effectively reduce depression symptoms with minimal side effects.
Protocol on transcranial alternating current stimulation for the treatment of major depressive disorder: a randomized controlled trial.Wang, HX., Wang, K., Zhang, WR., et al.[2023]

Citations

Transcranial Electrical Stimulation in Treatment of DepressionThis systematic review and meta-analysis evaluates outcomes of various transcranial electrical stimulation treatments in patients with major depressive disorder
Home-based transcranial direct current stimulation ...In summary, a 10-week course of home-based active tDCS was associated with greater improvements in depressive symptoms, clinical response and ...
Transcranial direct current stimulation in patients with ...Our analysis found a significant effect of tDCS on depression, with a Hedge's g = 0.66 (95 % CI: 0.565 to 0.767). Although studies aimed to ...
How effective is transcranial direct current stimulation?Reduction in left frontal alpha oscillations by transcranial alternating current stimulation in major depressive disorder is context dependent ...
Transcranial alternating current stimulation for the ...In summary, clinical tACS studies have shown promising improvements in alleviating MDD symptoms. However, we should note that the underlying modulation ...
Adverse events of tDCS and tACS: A review - PubMed CentralNo serious adverse effects have been reported in experiments using either tDCS or tACS. Persistent adverse effects of tDCS are mainly skin problems; ...
Transcranial Electrical Stimulation in Treatment of ...Transcranial direct current stimulation and transcranial alternating current stimulation was associated with positive outcomes among patients with MDD and DPC ...
Safety of Transcranial Direct Current Stimulation: Evidence ...This review updates and consolidates evidence on the safety of transcranial Direct Current Stimulation (tDCS).
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