Treating Depression With Transcranial Direct Current Stimulation (tDCS)

Phase 1

Completed

Interventions: Device: transcranial direct current stimulation
Device: iomed phoresor transcranial direct current stimulation

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.

Recruitment & Eligibility

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)

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

Arm && Interventions

Group	Intervention	Description
transcranial direct current stimulation	transcranial direct current stimulation	The active group of patients will receive active Iomed II Phoresor transcranial direct current stimulation for the first two weeks followed by another two weeks of active transcranial direct current stimulation.
sham tDCS	iomed phoresor transcranial direct current stimulation	The patients in the sham arm receive active Iomed II Phoresor transcranial direct current stimulation for the second two weeks of the clinical trial only. For the first two weeks the Iomed II Phoresor constant current generator is turned on for 10 seconds to produce the tingling sensation on the scalp experienced by the patients in the active arm but the generator is then turned off and the patients receive no stimulation for the remainder of the 20 minute session.

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