Active — Not RecruitingNot Applicable

Transcranial Electric Stimulation Therapy (TEST) for Treatment Resistant Depression (TRD)

United States8 participantsStarted 2022-11-08

Plain-language summary

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.

Who can participate

Age range25 Years – 64 Years

SexALL

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Inclusion criteria

✓. Provision of a signed and dated informed consent form.
✓. Stated willingness to comply with all study procedures and availability for the duration of the study.
✓. Male or female, ages 25 through 64 years.
✓. Meeting structured clinical interview for the DSM 5 (SCID) criteria for major depressive disorder, bipolar I disorder, or bipolar II disorder.
✓. Currently have TRD as defined by a major depressive episode with lack of remission of depressive symptoms following two trials of different medication or one medication trial and one rTMS trial approved for unipolar or bipolar depression at adequate dosage and duration treatment consistent with an Antidepressant Treatment History Form (ATHF) confidence level \>=3.
✓. Score \>= 25 on the Montgomery-Asberg Depression Rating Scale (MADRS) and a score \>=2 on item 1 at screening or for individuals with bipolar depression, score \>= 25 on the Bipolar Depression Rating Scale (BDRS) at screening.
✓. Score \<=12 on the Young Mania Rating Scale (YMRS) and a score \<= 1 on item 1 at screening.
✓. Willingness to: (a) provide written permission, as requested, to allow any and all forms of communication between the Investigator/Research Staff and any healthcare provider who currently provides and/or has provided service to the patient/subject within two years of study enrollment; and (b) provide the name and verifiable contact information of a person whom they trust to be an emergency contact whom research staff is at liberty to contact for the duration of study participation and who could serve as a legally authorized representative (LAR) if needed.

What they're measuring

Hopkins Verbal Learning Test-Revised (HVLT-R)

Timeframe: 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

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

Timeframe: every treatment throughout course (approximately 3x weekly)

Trial details

NCT IDNCT05172271

SponsorNational Institute of Mental Health (NIMH)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2027-07-31

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