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Treating Depression With Transcranial Direct Current Stimulation (tDCS)

Primary Purpose

Depression

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
transcranial direct current stimulation
transcranial direct current stimulation
transcranial direct current stimulation
iomed phoresor transcranial direct current stimulation
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring depression, transcranial direct current stimulation, direct current stimulation, tdcs

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

transcranial direct current stimulation

sham tDCS

Arm Description

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.

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.

Outcomes

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).
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
patient self report of depressive symptoms

Full Information

First Posted
June 1, 2007
Last Updated
May 17, 2013
Sponsor
New York State Psychiatric Institute
Collaborators
National Alliance for Research on Schizophrenia and Depression
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1. Study Identification

Unique Protocol Identification Number
NCT00481988
Brief Title
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

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Alliance for Research on Schizophrenia and Depression

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
depression, transcranial direct current stimulation, direct current stimulation, tdcs

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
transcranial direct current stimulation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
sham tDCS
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation
Other Intervention Name(s)
ioMed Phoresor
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation
Other Intervention Name(s)
Phoresor II Auto model PM850
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation
Other Intervention Name(s)
Phoresor II Auto model PM850
Intervention Description
one milliamp of direct current applied to the left dorsolateral prefrontal cortex through a scalp electrode
Intervention Type
Device
Intervention Name(s)
iomed phoresor transcranial direct current stimulation
Other Intervention Name(s)
phoresor II auto model PM850
Intervention Description
for the sham group the current is turned off after 10 seconds
Primary Outcome Measure Information:
Title
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).
Description
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.
Time Frame
Two weeks
Secondary Outcome Measure Information:
Title
Beck Depression Inventory II
Description
patient self report of depressive symptoms
Time Frame
Two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter M Bulow, MD
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York City
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
14211695
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.
Results Reference
background
PubMed Identifier
15753425
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.
Results Reference
background
Links:
URL
http://www.nimh.nih.gov/publicat/depression.cfm
Description
National Institute of Mental Health - Depression
URL
http://www.brainstimulation.columbia.edu/research/clinical/depression.html#TDCS
Description
Study summary on the Brain Stimulation Division web site

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Treating Depression With Transcranial Direct Current Stimulation (tDCS)

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