Efficacy of Cranial Electrotherapy Stimulation (CES) for the Treatment of Major Depressive Disorder
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|ClinicalTrials.gov Identifier: NCT03222752|
Recruitment Status : Recruiting
First Posted : July 19, 2017
Last Update Posted : August 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Device: Cranial Electrotherapy Stimulation Device: Sham Cranial Electrotherapy Stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||141 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A single site, 6 week, randomized, double-blind, placebo controlled evaluation of efficacy and tolerability of cranial electrotherapy stimulation (CES) for the treatment of adults from 18-65 years of age with treatment resistant Major Depressive Disorder (MDD) with a 2 week open label extension phase.|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||Treatment device will deliver subsensory treatment while the sham device will deliver no treatment.|
|Official Title:||A 6 Week, Randomized, Double-blind, Placebo Controlled Trial of the Efficacy and Tolerability of Cranial Electrotherapy Stimulation for the Treatment of Major Depressive Disorder, With a 2 Week Open Label Extension Phase.|
|Actual Study Start Date :||June 5, 2017|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
Active Comparator: Treatment Group
Group receives active treatment for 6 weeks. The intervention used will be cranial electrotherapy stimulation from and Alpha-Stim AID.
Device: Cranial Electrotherapy Stimulation
Alpha-Stim® AID microcurrent and cranial electrotherapy stimulator will be used. Daily one hour cranial electrotherapy stimulation (CES) treatment using ear clip electrodes with current set at fixed level of 100 uA (a subsensory current level), 0.5 Hertz will be used for active CES treatment group for 6 weeks. For the sham group the Alpha-Stim® AID ear clips will not emit electricity.
Other Name: Alpha-Stim
Sham Comparator: Sham Treatment Group
Groups receives treatment using sham cranial electrotherapy stimulation devices for 6 weeks. No actual treatment will be received. This group will not receive any treatment interventions. The same outcome measures will be used as the treatment group.
Device: Sham Cranial Electrotherapy Stimulation
The sham treatment will be using a sham Alpha-Stim AID which will look and sound exactly like the active treatment but will deliver no current.
Other Name: Sham Alpha-Stim
- Hamilton Depression Scale [ Time Frame: 6 weeks ]The Hamilton Rating Scale for Depression (HRSD), also called the Hamilton Depression Rating Scale (HDRS), abbreviated HAM-D, is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery.
- Clinical Global Impression - Severity of Illness [ Time Frame: 6 weeks ]The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis.
- Clinical Global Impression - Global Improvement [ Time Frame: 6 weeks ]The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03222752
|Contact: Michel Woodbury-Farina, MDfirstname.lastname@example.org|
|United States, Texas|
|Mineral Wells, Texas, United States, 76067|
|Contact: Jeff A Marksberry, MD 940-328-0788 email@example.com|
|Principal Investigator:||Michel Woodbury-Farina, MD||Univeristy of Puerto Rico|