Treating Depression With Transcranial Direct Current Stimulation (tDCS)

This study has been completed.
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00481988
First received: June 1, 2007
Last updated: May 17, 2013
Last verified: May 2013
  Purpose

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


Condition Intervention Phase
Depression
Device: transcranial direct current stimulation
Device: iomed phoresor transcranial direct current stimulation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double Blind Crossover Study of the Treatment of Major Depressive Episode With Transcranial Direct Current Stimulation (tDCS)

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Beck Depression Inventory II [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
    patient self report of depressive symptoms


Enrollment: 20
Study Start Date: March 2007
Study Completion Date: January 2011
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: phoresor II auto model PM850

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00481988

Locations
United States, New York
New York State Psychiatric Institute
New York City, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
National Alliance for Research on Schizophrenia and Depression
Investigators
Principal Investigator: Peter M Bulow, MD New York State Psychiatric Institute
  More Information

Additional Information:
Publications:
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00481988     History of Changes
Other Study ID Numbers: 5405
Study First Received: June 1, 2007
Results First Received: December 6, 2012
Last Updated: May 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by New York State Psychiatric Institute:
depression
transcranial direct current stimulation
direct current stimulation
tdcs

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 28, 2014