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

Primary Purpose

Therapy Resistant Major Depression

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Transcranial direct current stimulation (tDCS) - Eldith DC-Stimulator
Sponsored by
Ludwig-Maximilians - University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Therapy Resistant Major Depression focused on measuring tDCS, major depression

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Psychiatry and Psychotherapy, Ludwig-Maximilian University Munich

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

1

2

Arm Description

anodal tDCS

Sham tDCS

Outcomes

Primary Outcome Measures

Hamilton Psychiatric Rating Scale for Depression (HRSD-24)

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)

Full Information

First Posted
April 24, 2008
Last Updated
November 13, 2009
Sponsor
Ludwig-Maximilians - University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT00667680
Brief Title
Transcranial Direct Current Stimulation (tDCS) in Treatment-resistant Depression
Official Title
Transcranial Direct Current Stimulation (tDCS) in Treatment-resistant Depression - Effect on Clinical and Neurophysiological Parameters
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ludwig-Maximilians - University of Munich

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Therapy Resistant Major Depression
Keywords
tDCS, major depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
anodal tDCS
Arm Title
2
Arm Type
Sham Comparator
Arm Description
Sham tDCS
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation (tDCS) - Eldith DC-Stimulator
Other Intervention Name(s)
Eldith DC - Stimulator (neuroConn GmbH, Ilmenau, Germany)
Intervention Description
real or sham tDCS for 20 minutes at 2mA intensity over the left DLPFC (F3 according to the 10-20 system)
Primary Outcome Measure Information:
Title
Hamilton Psychiatric Rating Scale for Depression (HRSD-24)
Time Frame
6
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Padberg, MD, PhD
Organizational Affiliation
Dept. of Psychiatry, Ludwig-Maximilians-University Munich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry and Psychotherapy, Ludwig-Maximilian University Munich
City
Munich
ZIP/Postal Code
80336
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://psywifo.klinikum.uni-muenchen.de/forschung/tms/indexeng.html
Description
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Transcranial Direct Current Stimulation (tDCS) in Treatment-resistant Depression

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