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

Completed · Not applicable · Has a placebo group

Conditions studied: Depression

In brief

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.

Key facts

Study ID

NCT03277846

Run by

University of Pennsylvania

People needed

101

Starts

2017-09-01

Expected to finish

2018-05-17

Last updated by the study team

2019-10-28

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• In-patients at the Carrier Clinic
• Adults over age 18 and under age 65
• Able to speak, read and write fluently in English, assessed by the study coordinator at Carrier Clinic
• Screened Negative for alcohol abuse and/or dependence
• Able to provide informed consent, assessed by the study coordinator at Carrier Clinic
• Referred for ECT
• Not currently taking hypnotics or be prescribed hypnotics during the Nexalin trial
• Not pregnant or intending to become pregnant during the study
• Committed to completion of the study
• Exclusion Criteria: Medically or psychiatrically unstable, where the severity of the illness prohibits the subject from engaging in study procedures.

Where it is running

• Carrier Clinic — Belle Mead, New Jersey, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.