Treating Depression With Transcranial Direct Current Stimulation (tDCS)

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00481988
• Other study ID #: 5405
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 1, 2007
• Last updated: May 17, 2013
• Start date: March 2007
• Est. completion date: January 2011

Study information

• Verified date: May 2013
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2011
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

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)

• 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Device:
• transcranial direct current stimulation
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.
• transcranial direct current stimulation
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.
• transcranial direct current stimulation
one milliamp of direct current applied to the left dorsolateral prefrontal cortex through a scalp electrode
• iomed phoresor transcranial direct current stimulation
for the sham group the current is turned off after 10 seconds

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York City	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Alliance for Research on Schizophrenia and Depression

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Beck Depression Inventory II	patient self report of depressive symptoms	Two weeks	No

External Links

•   Study summary on the Brain Stimulation Division web site