The Safety and Efficacy of Nexalin Trans-cranial Electrical Stimulation Stimulation for the Treatment of Depression
| Status: | Completed |
|---|---|
| Conditions: | Depression, Depression |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 3/2/2019 |
| Start Date: | September 1, 2017 |
| End Date: | May 17, 2018 |
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of Nexalin Electrical Brain Stimulation for the Treatment of Depression in Patients Referred to Electro-Convulsive Therapy
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.
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.
A 2x2 factor Randomized Controlled Trial with block randomization. Inpatient subjects at the
Carrier Clinic who are referred for ECT will be recruited, typed regarding their acceptance
of ECT, and randomized to either treatment with TES or to a Sham condition. Treatment
non-responders in either condition will continue as in patients at the Carrier Clinic until
they reach acceptable levels of functioning to be discharged
Carrier Clinic who are referred for ECT will be recruited, typed regarding their acceptance
of ECT, and randomized to either treatment with TES or to a Sham condition. Treatment
non-responders in either condition will continue as in patients at the Carrier Clinic until
they reach acceptable levels of functioning to be discharged
Inclusion Criteria:
1. In-patients at the Carrier Clinic
2. Adults over age 18 and under age 65
3. Able to speak, read and write fluently in English, assessed by the study coordinator
at Carrier Clinic
4. Screened Negative for alcohol abuse and/or dependence
5. Able to provide informed consent, assessed by the study coordinator at Carrier Clinic
6. Referred for ECT
7. Not currently taking hypnotics or be prescribed hypnotics during the Nexalin trial
8. Not pregnant or intending to become pregnant during the study
9. 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.
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