Depression Clinical Trial
Official title:
Transcranial Direct Current Stimulation for Treatment of Depression in Parkinson's Disease, a Randomized Placebo-controlled Clinical Trial
NCT number | NCT02960464 |
Other study ID # | HSMarcelina |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | November 8, 2016 |
Last updated | November 9, 2016 |
Start date | October 2016 |
Investigation of possible benefits of transcranial direct current stimulation (tDCS) as a treatment of depression in patients with Parkinson's Disease, through a randomized placebo-controlled clinical trial.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | |
Est. primary completion date | June 2018 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 35 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Idiopathic Parkinson's Disease - Geriatric Depression Scale - 15 higher that 5 - Major Depression Disorder Exclusion Criteria: - CNS disease other than Parkinson's Disease (i.e. epilepsy, stroke) - Mental disorder other than depression on anxiety disorder (i.e. bipolar disorder, schizophrenia) - Previous neurosurgical intervention (i.e. DBS) - Current use of antidepressant drug - High suicidality risk - Limited capacity of understanding written and spoken Portuguese |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital Santa Marcelina | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
Hospital Santa Marcelina |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hamilton Rating Scale for Depression | 8 weeks | No | |
Secondary | Montgomery-Åsberg Depression Rating Scale | 8 weeks | No | |
Secondary | Mini-Mental State Examination | 8 weeks | No | |
Secondary | Hamilton Anxiety Rating Scale | 8 weeks | No | |
Secondary | Geriatric Depression Scale -15 | 8 weeks | No | |
Secondary | Parkinson's Disease Questionnaire - 39 | 8 weeks | No | |
Secondary | Lille apathy rating scale | 8 weeks | No | |
Secondary | Quantitative EEG | 8 weeks | No |
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