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Transcranial Direct Current Stimulation (tDCS) in Treatment-resistant Depression

This study has been completed.
Sponsor:
Information provided by:
Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT00667680
First received: April 24, 2008
Last updated: November 13, 2009
Last verified: November 2009
History of Changes
  Purpose

tDCS applies a small amount of direct electric current (DC) to the brain by means of two electrodes: the one is an active electrode, localized on the effective site, and the other is a reference electrode, localized on some "silent" part of the body. Anodal transcranial direct current stimulation (tDCS) of the left dorsolateral prefrontal cortex (DLPFC) has been associated with working memory enhancement and improvement of mood. This study will investigate the possible antidepressant effects of tDCS in patients with therapy resistant major depressive episodes.


Condition Intervention Phase
Therapy Resistant Major Depression
 Device: Transcranial direct current stimulation (tDCS) - Eldith DC-Stimulator
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation (tDCS) in Treatment-resistant Depression - Effect on Clinical and Neurophysiological Parameters

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:
  • Hamilton Psychiatric Rating Scale for Depression (HRSD-24) [ Time Frame: 6 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Beck depression Inventory (BDI) Clinical Global Impression (CGI) Mini-Mental-Status-Test (MMST) Verbal Learning and Memory Test (VLMT) Regensburger Word Fluency Test (RWT) [ Time Frame: 4 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: March 2007
Study Completion Date: November 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
anodal tDCS
 Device: Transcranial direct current stimulation (tDCS) - Eldith DC-Stimulator
real or sham tDCS for 20 minutes at 2mA intensity over the left DLPFC (F3 according to the 10-20 system)
Other Name: Eldith DC - Stimulator (neuroConn GmbH, Ilmenau, Germany)
Sham Comparator: 2
Sham tDCS
 Device: Transcranial direct current stimulation (tDCS) - Eldith DC-Stimulator
real or sham tDCS for 20 minutes at 2mA intensity over the left DLPFC (F3 according to the 10-20 system)
Other Name: Eldith DC - Stimulator (neuroConn GmbH, Ilmenau, Germany)

Detailed Description:

Transcranial direct current stimulation (tDCS) is a non-invasive method that shifts membrane potential towards hypo- or hyperpolarization and therefore leads to functional changes in a discrete area of the cerebral cortex.

Neurophysiological studies have shown that slow changes in cortical scalp potential reflect overall activity of cortical neuronal networks. These scalp potentials reflect shifts in membrane potentials of the cortical neurons. Over the past 7 years tDCS has evolved as an important tool to non-invasively manipulate specific neural circuits of the human brain.

The purpose of this study is an investigation of tDCS applied to 20 therapy-resistance major depressive patients. Our hypothesis is that tDCS may exert an antidepressant effect and/or enhances the medication effect. tDCS will be examined in the framework of a placebo-controlled clinical pilot-study investigating effectiveness, safety and influence on EEG parameters. Patients will receive anodal DC stimulation or sham stimulation (extra designed placebo-stimulator) in a double-blind design over 10 days for each condition. Outcomes will be evaluated using several clinical, psychiatric and neuropsychological rating scales.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-75 years
  • At least moderate major depressive episode (DSM IV criteria).
  • Stable total pre-treatment Hamilton Rating Scale for Depression score ≥18
  • Therapy-resistance during current depressive episode (according to ATHF).
  • The patient must be in the condition to understand the patient-information, as well as the necessary examinations. He/she must be able to give a written consent.
  • Stable antidepressant medication, that is retained during the study- duration, from at least three weeks before the begin of the study.

Exclusion Criteria:

  • Existence of a care/legal incapacity
  • Existing pregnancy
  • Severe psychiatric illness (with exception of affective disorder)
  • Acute suicidality
  • Drug-, medication- or alcohol dependence
  • Dementia according to DSM IV / ICD 10-criterions
  • Severe TBI in the anamnesis
  • Indications of structural damage of the basal ganglia or the brain stem
  • Severe neurological disorders (e.g. M. Parkinson, epilepsy, discus-prolapse, dementia, systemic neurological illnesses, normal pressure hydrocephalus, cerebrovascular diseases, elevated intracranial pressure, in the last 6 months, polyneuropathies).
  • Severe other medical conditions, like manifest arterial hypertonia, severe heart disease, pacemakers, respiratory failure, malignant illnesses all type, also in the history, active infectious diseases, skeletal disorders (like M. Paget, osteoporosis with spontaneous fractures, fresh fractures)
  • Other circumstances, that speaks against a participation of the patient pinion of MD at this study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00667680

Locations
Germany
Department of Psychiatry and Psychotherapy, Ludwig-Maximilian University Munich
Munich, Germany, 80336
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Investigators
Principal Investigator: Frank Padberg, MD, PhD Dept. of Psychiatry, Ludwig-Maximilians-University Munich
  More Information

No publications provided

Responsible Party: Frank Padberg, MD, PhD, Dept. of Psychiatry, Ludwig-Maximilians-University Munich
ClinicalTrials.gov Identifier: NCT00667680     History of Changes
Other Study ID Numbers: 01/2007
Study First Received: April 24, 2008
Last Updated: November 13, 2009
Health Authority: Germany: Ethics Commission

Keywords provided by Ludwig-Maximilians - University of Munich:
tDCS, major depression

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

ClinicalTrials.gov processed this record on June 17, 2013