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Completed

NCT Number: NCT00481988

Treating Depression With Transcranial Direct Current Stimulation (tDCS)

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

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

New York State Psychiatric Institute

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Direct Current Stimulation

Device

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.

Other names: ioMed Phoresor

iomed phoresor transcranial direct current stimulation

Device

for the sham group the current is turned off after 10 seconds

Other names: phoresor II auto model PM850

Primary outcomes

  1. 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).

    Time frame: 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 outcomes

  1. Beck Depression Inventory II

    Time frame: Two weeks

    patient self report of depressive symptoms

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • National Alliance for Research on Schizophrenia and Depression

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2011
First posted
Jun 4, 2007
Registry last updated
May 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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