Treating Depression With Transcranial Direct Current Stimulation (tDCS)

Study Overview
=================
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.

Official Title
-----------------
Randomized, Double Blind Crossover Study of the Treatment of Major Depressive Episode With Transcranial Direct Current Stimulation (tDCS)

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Device: transcranial direct current stimulation
* Device: transcranial direct current stimulation
* Device: transcranial direct current stimulation
* Device: iomed phoresor transcranial direct current stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: transcranial direct current stimulation<br>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. | Device: transcranial direct current stimulation<br>* Two damp sponges, one placed on the left side of the forehead, the other on the left arm. 0.1mA of current is passed for 20 minutes.<br>* Other names: ioMed Phoresor;Device: transcranial direct current stimulation<br>* transcranial direct current stimulation delivers one milliamp of direct current, supplied by a constant current generator, the the left dorsolateral prefrontal cortex through a scalp electrode. The treatment is given for 20 minutes a day.<br>* Other names: Phoresor II Auto model PM850;Device: transcranial direct current stimulation<br>* one milliamp of direct current applied to the left dorsolateral prefrontal cortex through a scalp electrode<br>* Other names: Phoresor II Auto model PM850;|
| Sham Comparator: sham tDCS<br>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. | Device: iomed phoresor transcranial direct current stimulation<br>* for the sham group the current is turned off after 10 seconds<br>* Other names: phoresor II auto model PM850;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | Two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Depression Inventory II | patient self report of depressive symptoms | Two weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
depression, transcranial direct current stimulation, direct current stimulation, tdcs