Treating Depression With Transcranial Direct Current Stimulation (tDCS)

May 17, 2013 updated by: New York State Psychiatric Institute

Randomized, Double Blind Crossover Study of the Treatment of Major Depressive Episode 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York City, New York, United States, 10032
        • New York State Psychiatric Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: transcranial direct current stimulation
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
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
Device: 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.
Other Names:
  • Phoresor II Auto model PM850
Device: transcranial direct current stimulation
one milliamp of direct current applied to the left dorsolateral prefrontal cortex through a scalp electrode
Other Names:
  • Phoresor II Auto model PM850
Sham Comparator: sham tDCS
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
for the sham group the current is turned off after 10 seconds
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).
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.
Two weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Collaborators

National Alliance for Research on Schizophrenia and Depression

Investigators

  • Principal Investigator: Peter M Bulow, MD, New York State Psychiatric Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

June 1, 2007

First Submitted That Met QC Criteria

June 1, 2007

First Posted (Estimate)

June 4, 2007

Study Record Updates

Last Update Posted (Estimate)

May 20, 2013

Last Update Submitted That Met QC Criteria

May 17, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5405 (OHSU Knight Cancer Institute)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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