Therapy Resistant Major Depression Clinical Trial
Official title:
Transcranial Direct Current Stimulation (tDCS) in Treatment-resistant Depression - Effect on Clinical and Neurophysiological Parameters
| Verified date | November 2009 |
| Source | Ludwig-Maximilians - University of Munich |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Ethics Commission |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | November 2008 |
| Est. primary completion date | September 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | Department of Psychiatry and Psychotherapy, Ludwig-Maximilian University Munich | Munich |
| Lead Sponsor | Collaborator |
|---|---|
| Ludwig-Maximilians - University of Munich |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Hamilton Psychiatric Rating Scale for Depression (HRSD-24) | 6 | Yes | |
| Secondary | Beck depression Inventory (BDI) Clinical Global Impression (CGI) Mini-Mental-Status-Test (MMST) Verbal Learning and Memory Test (VLMT) Regensburger Word Fluency Test (RWT) | 4 | Yes |