Clinical trial NCT00481988: Treating Depression With Transcranial Direct Current Stimulation (tDCS)
Official title: Randomized, Double Blind Crossover Study of the Treatment of Major Depressive Episode With Transcranial Direct Current Stimulation (tDCS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Depression
Keywords: depression
transcranial direct current stimulation
direct current stimulation
tdcs
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Alliance for Research on Schizophrenia and Depression
First posted: 2007-06-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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).
timeFrame: Two weeks
Secondary outcomes:
measure: Beck Depression Inventory II
timeFrame: Two weeks
Other outcomes:
Locations:
city: New York City
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: Peter M Bulow, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: COSTAIN R, REDFEARN JW, LIPPOLD OC. A CONTROLLED TRIAL OF THE THERAPEUTIC EFFECT OF POLARIZATION OF THE BRAIN IN DEPRESSIVE ILLNESS. Br J Psychiatry. 1964 Nov;110:786-99. doi: 10.1192/bjp.110.469.786. No abstract available.
citation: Iyer MB, Mattu U, Grafman J, Lomarev M, Sato S, Wassermann EM. Safety and cognitive effect of frontal DC brain polarization in healthy individuals. Neurology. 2005 Mar 8;64(5):872-5. doi: 10.1212/01.WNL.0000152986.07469.E9.