Treating Depression With Transcranial Direct Current Stimulation (tDCS)

New York State Psychiatric Institute

Status and phase: Completed; Phase 2; Phase 1

Conditions: Depression

Treatments: Device: iomed phoresor transcranial direct current stimulation; Device: transcranial direct current stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT00481988

5405

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

transcranial direct current stimulation

Active Comparator group

Description:

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.

Treatment:

Device: transcranial direct current stimulation

Device: transcranial direct current stimulation

Device: transcranial direct current stimulation

sham tDCS

Sham Comparator group

Description:

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.

Treatment:

Device: iomed phoresor transcranial direct current stimulation