Adjunctive Transcranial Direct Current Stimulation for Cognition in Major Depression

NCT00760097 | Completed Phase 4 DMC

• 1 other identifier: aTDCS in MDD
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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, 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").

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• To test our hypotheses, assessments of cognition, mood, and brain activity will be performed on three occasions

  6 visits

Secondary Outcomes (1)

• ADVERSE EVENT REPORTS Subjects will be asked about adverse events at the end of each treatment session

  6 visits

Study Arms (1)

AtCDS

EXPERIMENTAL

Transcranial direct stimulation

Device: Transcranial direct stimulation

Interventions

Transcranial direct stimulation DEVICE

sessions of 20 minutes each

AtCDS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Semel Institute for Neuroscience

Los Angeles, California, 90024, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Ian Cook, Dr.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 24, 2008
• First Posted: September 25, 2008
• Study Start: September 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: February 6, 2013

Record last verified: 2013-02

Locations

US (1)