Adjunctive Transcranial Direct Current Stimulation for Cognition in Major Depression

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00760097
• Date of registration: 24/09/2008
• Prospective Registration: No
• Primary sponsor: University of California, Los Angeles
• Public title: Adjunctive Transcranial Direct Current Stimulation for Cognition in Major Depression aTDCS
• Scientific title: Adjunctive Transcranial Direct Current Stimulation for Cognition in Major Depression
• Date of first enrolment: September 2007
• Target sample size: 18
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00760097
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Ian Cook, Dr.
• Affiliation: University of California, Los Angeles

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Depression

Intervention(s)

Device: Transcranial direct stimulation

Primary Outcome(s)

To test our hypotheses, assessments of cognition, mood, and brain activity will be performed on three occasions [Time Frame: 6 visits]

Secondary Outcome(s)

ADVERSE EVENT REPORTS Subjects will be asked about adverse events at the end of each treatment session [Time Frame: 6 visits]

Secondary ID(s)

aTDCS in MDD

Source(s) of Monetary Support

Please refer to primary and secondary sponsors