Who is sponsoring NCT03277846?

NCT03277846 is sponsored by University of Pennsylvania.

What drugs are being tested in NCT03277846?

Interventions in NCT03277846: Nexalin Based Trans-Cranial Electrical Stimulation.

What condition does NCT03277846 study?

NCT03277846 studies Depression.

Is NCT03277846 still recruiting?

NCT03277846 is currently completed. Last updated 28 October 2019.

Are results published for NCT03277846?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-10-28 · How we verify

NCT03277846: TES

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The Safety and Efficacy of Nexalin Trans-cranial Electrical Stimulation Stimulation for the Treatment of Depression

Completed NA Results posted Last updated 28 October 2019

What this trial tests

NA trial testing Nexalin Based Trans-Cranial Electrical Stimulation in Depression in 101 participants. Completed in 17 May 2018.

Timeline

1 September 2017

Primary endpoint
17 May 2018

17 May 2018

Quick facts

Lead sponsor	University of Pennsylvania
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	101
Start date	1 September 2017
Primary completion	17 May 2018
Estimated completion	17 May 2018
Sites	1 location across United States

Drugs / interventions tested

Nexalin Based Trans-Cranial Electrical Stimulation

Conditions studied

Depression — all drugs for Depression →

Sponsor

University of Pennsylvania

Who can join

Adults 18 to 65, any sex, with Depression. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Treatment Response Primary · 1-2 weeks

Percent responders to TES treatment and Sham TES (50% reduction or a score below 10 on the PHQ-9). The PHQ-9 is a 9 item scale, where each item ranges from 0 to 3. Zero represents "not at all" and 3 represents "nearly every day". The scale ranges from 0-27. We used percent change (from admission to "ex-take") as a our metric.

Group	Value	95% CI
Transcranial Electrical Stimulation	28
TES-SHAM	29

Sponsor's own description

The purpose of this research study is to determine whether Nexalin Trans-Cranial Electrical Stimulation (TES) is an effective treatment for depression among patients who are candidates for ECT. A secondary aim to assess whether Nexalin can be used as an alternative to ECT. Although Nexalin has been approved for use in the US, using Nexalin to treat depression in this way is investigational and experimental. If Nexalin is found to be an alternative to ECT, it could offer a safer treatment for depression with less side-effects and a lower cost. !!! NOTE !!! Post Script / Post Study. The ECT arm (profiling subjects as ECT accepters vs. rejecters) was dropped owing to site objections by referring clinicians. Accordingly, the study was framed as a simple comparison between TES and SHAM TES.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Other University of Pennsylvania trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03277846 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Pennsylvania
Last refreshed: 28 October 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03277846.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing