Treating Depression With Transcranial Direct Current Stimulation (tDCS)

Phase 1

Completed

• Conditions: Depression

• Registration Number: NCT00481988
• Lead Sponsor: New York State Psychiatric Institute

Brief Summary

The purpose of this study is to see if transcranial direct current stimulation may improve the symptoms of depression.

Detailed Description

The purpose of this study is to learn about a brain stimulating procedure called transcranial direct current stimulation (tDCS). In tDCS therapy, two moistened sponges are applied to the forehead while a small amount of electric current flows between them. These electrodes are placed on the head so that the electricity will pass through a region in the brain that is believed to contribute to depression. This study is intended to test the theory that the electromagnetic field created by the current may affect this region of the brain in a way that may improve the symptoms of depression. This may affect brain activity and function.

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-06-01
• Study First Submitted QC: 2007-06-01
• Study First Posted: 2007-06-04
• Primary Completion: 2009-06
• Study Completion: 2011-01
• Results First Submitted: 2012-12-06
• Status Verified: 2013-05
• Results First Submitted QC: 2013-05-17
• Last Update Submitted: 2013-05-17
• Results First Posted: 2013-05-20
• Last Update Posted: 2013-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Has a diagnosis of a major depressive episode or bipolar disorder and is currently in a major depressive episode (without psychotic features)
• Total pretreatment HDRS (Hamilton Depression Rating Scale)-24 score >= 18 (The Hamilton Depression Rating Scale is an interviewer scored tool for assessing the severity of depressive symtoms. The scale ranges from 0 (no symptoms, absence of depression) to 64

Category Ham-24 Score Normal, not depressed 9 or less Mildly depressed 10 to 19 Moderately depressed 20 to 29 Markedly/severely depressed 30 or more)

• Capable and willing to provide informed consent

Exclusion Criteria

• History of depression previously untreated with medication, bipolar disorder, schizophrenia, schizoaffective disorder (non mood disorder), psychosis, depression secondary to a medical condition, mental retardation, substance dependence or abuse within the past year (except nicotine), psychotic features in this or previous episodes, amnestic disorder, dementia or mms<24, DELIRIUM
• Significant current history of autoimmune, endocrine, viral or vascular disorder affecting the brain
• History of unstable cardiac disease, uncontrolled hypertension, or sleep apnea
• Changes in psychotropic medications within two weeks prior to study entry or patient is unable to maintain stable doses throughout the study trial
• Subject has an active suicidal plan and/or attempted suicide in the past twelve months
• Patients with a CGI of 6 or greater
• Subject is pregnant or has a positive pregnancy serum test

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hamilton Rating Scale for Depression (24 Question Version), a Standardized Assessment Tool for Measuring Severity of Depression Where 0 is the Minimum Score (no Depressive Symptoms) and 40 is the Maximum (Severe Depression).	Two weeks	The Hamilton Rating Scale for Depression (HRS,24 question version), is a standardized assessment tool for measuring severity of depression where 0 is the minimum score (no depressive symptoms) and 40 is the maximum (severe depression).I am reporting the number of participants with stable remission which is defined as an HDRS \< 10 for 2 weeks.

Secondary Outcome Measures

Name	Time	Method
Beck Depression Inventory II	Two weeks	patient self report of depressive symptoms

Trial Locations

Locations (1)

New York State Psychiatric Institute; 🇺🇸 New York City, New York, United States