Status:
COMPLETED
Adjunctive Transcranial Direct Current Stimulation for Cognition in Major Depression
Lead Sponsor:
University of California, Los Angeles
Conditions:
Depression
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
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, an...
Detailed Description
Transcranial direct current stimulation (tDCS), also sometimes termed "DC polarization" or "brain polarization," is a non-invasive procedure that has been used successfully as a therapeutic interventi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00760097
Start Date
September 1 2007
End Date
May 1 2009
Last Update
February 6 2013
Active Locations (1)
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1
UCLA Semel Institute for Neuroscience
Los Angeles, California, United States, 90024