Treating Depression With Transcranial Direct Current Stimulation (tDCS)

NCT00481988 | Completed Phase 1 Results DMC

• 1 other identifier: 5405
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Depression

Keywords

depression; transcranial direct current stimulation; direct current stimulation; tdcs

Outcome Measures

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).

  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 Outcomes (1)

• Beck Depression Inventory II

  Two weeks

Study Arms (2)

transcranial direct current stimulation

ACTIVE COMPARATOR

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

sham tDCS

SHAM COMPARATOR

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

Interventions

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.

Also known as: ioMed Phoresor

transcranial direct current stimulation

iomed phoresor transcranial direct current stimulation DEVICE

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

Also known as: phoresor II auto model PM850

sham tDCS

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Alliance for Research on Schizophrenia and Depression: collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related 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. doi: 10.1192/bjp.110.469.786. No abstract available.

  PMID: 14211695 BACKGROUND

• 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.

  PMID: 15753425 BACKGROUND

Related Links

• National Institute of Mental Health - Depression
• Study summary on the Brain Stimulation Division web site

MeSH Terms

Conditions

Depression

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Limitations and Caveats

Data for the secondary outcome measure (Beck Depression Inventory) was incompletely collected and not analyzed.

Results Point of Contact

• Title: Peter Bulow MD, Assistant Professor of Clinical Psychiatry
• Organization: Division of Experimental Therapeutics, NY State Psychiatric Organization

pb2182@columbia.edu

(212) 543 5664

Study Officials

• Peter M Bulow, MD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2007
• First Posted: June 4, 2007
• Study Start: March 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: January 1, 2011
• Last Updated: May 20, 2013
• Results First Posted: May 20, 2013

Record last verified: 2013-05

Locations

US (1)