Depression Clinical Trial
— aTDCSOfficial title:
Adjunctive Transcranial Direct Current Stimulation for Cognition in Major Depression
People who have depression often have symptoms besides sad mood. Cognitive symptoms, such as poor memory, concentration, and decision making, are associated with disability in many spheres of life, and these symptoms often persist even when antidepressant treatment improves other symptoms (mood, energy, sleep, anxiety). Antidepressants alone fail to produce full remission for many patients, so it is important to study adjunctive treatments which can be added onto medication treatment and help restore cognitive function. The method of transcranial direct current stimulation (tDCS) has been shown by others to improve working memory and cognitive functions, and also to help with other symptoms of depression. tDCS involves passing a small, constant current between saline-moistened pads placed on the scalp. In this proposed study, 20 individuals with major depression who have cognitive difficulties despite taking antidepressants will participate. Over the course of a two-week period, each person will receive 5 sessions of either active tDCS or inactive treatments, in addition to their medication. Each session lasts for 20 minutes, and will be administered on alternating days (M-W-F). Assessments of depressive symptoms, cognitive function, and brain activity will be made prior to any sessions, after the first one, and after the fifth (final) session; brain function will be assessed by measuring the brain's electrical activity ("brain waves").
Status | Completed |
Enrollment | 18 |
Est. completion date | May 2009 |
Est. primary completion date | May 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Subject age is 18 to 75 years old - Subject meets the DSM-IV diagnosis of Major Depressive Disorder based on the MINI, with a current major depressive episode in partial remission - Subject has been receiving treatment with an antidepressant medication for = 3 months at a therapeutic dose. Therapeutic doses will be operationalized as those ranges noted by the drug manufacturers in their respective Package Inserts. - Subject's score on the 17-item Hamilton Depression Rating Scale (Ham-D) is > 8 despite treatment with antidepressant medication(s). - Subject has subjective cognitive complaints. Exclusion Criteria: - Subject is mentally or legally incapacitated, unable to give informed consent - Subject suffering from a cognitive, bipolar, or psychotic disorder on the on the basis of a MINI interview; in situations where there is ambiguity about the origin of cognitive symptoms (i.e. depression with cognitive symptoms VS early dementia) subjects will not be enrolled. - Subject meeting criteria for an Axis II diagnosis that would interfere with completion of the protocol - Known drug dependency or substance abuse within the past six months - Subject has had a course of ECT, Transcranial Magnetic Stimulation (TMS), or Vagus Nerve Stimulation (VNS) within the six months prior to enrollment - Unstable medical illness, any history of seizures, brain surgery, skull fracture, significant head trauma, or previous abnormal EEG - Ham-D score > 25 despite pharmacotherapy - Subject is a UCLA student or staff member directly under instruction or employment of any of the investigators - Subject has a medical illness which might be exacerbated by tDCS treatments (e.g. skin abrasions or infection of the scalp might be exacerbated by the placement of the saline-moistened electrode pads) - Subject is using any of the following medications which interfere with EEG measures of brain function: Anticholinergics, Barbiturates, Benzodiazepines, Sedating Antihistamines (e.g. diphenhydramine (Benadryl) would be exclusionary, but not loratadine (Claritin)). - Subject declines to give the study personnel permission to discuss their depression and participation in this study with their treating physician. - Subject has had a suicide attempt or other self-injurious behavior in the past 6 months - Subject has an implanted pacemaker - Subject has red/green colorblindness (cannot distinguish red from green) - Subject's intake urine test is positive for drugs of abuse |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | UCLA Semel Institute for Neuroscience | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To test our hypotheses, assessments of cognition, mood, and brain activity will be performed on three occasions | 6 visits | No | |
Secondary | ADVERSE EVENT REPORTS Subjects will be asked about adverse events at the end of each treatment session | 6 visits | Yes |
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