Empower: tDCS for Major Depressive Disorder at Home
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05202119|
Recruitment Status : Active, not recruiting
First Posted : January 21, 2022
Last Update Posted : April 20, 2023
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Device: Transcranial direct current stimulation Device: Sham Transcranial direct current stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||270 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||Participants and investigators are unaware of what stimulation (active or sham) the device delivers.|
|Official Title:||Empower: Transcranial Direct Current Stimulation in Major Depressive Disorder: a Double-blind, Placebo-controlled, Randomized, Superiority Trial|
|Actual Study Start Date :||May 1, 2022|
|Estimated Primary Completion Date :||May 25, 2023|
|Estimated Study Completion Date :||August 31, 2023|
Active Comparator: Active stimulation
Active stimulation at 2mA
Device: Transcranial direct current stimulation
Transcranial direct current stimulation (tDCS) a non-invasive brain stimulation technique where a weak direct current (2 mA) is applied on the scalp through electrodes. The current modulates the underlying neural activity. The sessions are 30 minutes, 3-5 time a week.
|Sham Comparator: Sham stimulation||
Device: Sham Transcranial direct current stimulation
To blind the participants of the stimulation, a standardized sham protocol is used where the current ramped up and then down breifly in the beginning and end of each session to simulate active stimulation.
- HDRS-17 [ Time Frame: 10 weeks ]Mean score change based on HDRS-17 scores of the two arms at 10 weeks compared to baseline.
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): NCT05202119
|United States, Texas|
|UT Health Science Center|
|Houston, Texas, United States, 77030|
|School of Psychology, University East London|
|London, United Kingdom, E16 2RD|