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

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ClinicalTrials.gov Identifier: NCT00667680
Recruitment Status : Completed
First Posted : April 28, 2008
Last Update Posted : November 16, 2009
Sponsor:
Information provided by:
Ludwig-Maximilians - University of Munich

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Therapy Resistant Major Depression Device: Transcranial direct current stimulation (tDCS) - Eldith DC-Stimulator Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation (tDCS) in Treatment-resistant Depression - Effect on Clinical and Neurophysiological Parameters
Study Start Date : March 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : November 2008

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Arms and Interventions
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Arm Intervention/treatment
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)


Outcome Measures
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Primary Outcome Measures :
  1. Hamilton Psychiatric Rating Scale for Depression (HRSD-24) [ Time Frame: 6 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00667680


Locations
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Germany
Department of Psychiatry and Psychotherapy, Ludwig-Maximilian University Munich
Munich, Germany, 80336
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Investigators
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Principal Investigator: Frank Padberg, MD, PhD Dept. of Psychiatry, Ludwig-Maximilians-University Munich
More Information
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Responsible Party: Frank Padberg, MD, PhD, Dept. of Psychiatry, Ludwig-Maximilians-University Munich
ClinicalTrials.gov Identifier: NCT00667680    
Other Study ID Numbers: 01/2007
First Posted: April 28, 2008    Key Record Dates
Last Update Posted: November 16, 2009
Last Verified: November 2009
Keywords provided by Ludwig-Maximilians - University of Munich:
tDCS, major depression
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Depressive Disorder, Treatment-Resistant
 Behavioral Symptoms
Mood Disorders
Mental Disorders