Transcranial Direct Current Stimulation in Major Depression

Completed · Not applicable · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

Noninvasive transcranial direct current stimulation (tDCS) is a low-intensity neuromodulation technique of minimal risk that has been used as an experimental procedure for reducing depressive symptoms and symptoms of other brain disorders. Though tDCS applied to prefrontal brain areas is shown to reduce symptoms in some people with major depressive disorder (MDD), the extent of antidepressant response often differs. Methods that map current flow directly in the brain while a person is receiving tDCS and that determine how functional neuroimaging signal changes after a series of tDCS sessions may help us understand how tDCS works, how it can be optimized, and if it can be used as an effective intervention for reducing depressive symptoms. We will investigate these questions in a two-part randomized double blind exploratory clinical trial. The first part of the trial will compare how current flow and functional imaging signal differs in the brain when using tDCS with more focal stimulation, called high definition (HD) tDCS, compared to conventional tDCS (C-tDCS) or sham (non-active) tDCS in patients with MDD. Sixty people with depression (20 in each group) will be randomized to receive either HD-tDCS, C-tDCS or sham-tDCS for a total of 12 sessions each lasting 20 minutes occurring on consecutive weekdays. At the first and last session, subjects will receive 20-30 minutes of active or sham tDCS in the MRI scanner, which will allow us to map tDCS currents, and track changes in regional cerebral blood flow (rCBF) pre-to- post treatment using completely non-invasive methods. At the first and last session and mid-way through the trial, participants will also complete a series of clinical ratings and neurocognitive tests

Key facts

Study ID: NCT03556124
Run by: University of California, Los Angeles
People needed: 66
Starts: 2018-02-02
Expected to finish: 2020-05-31
Last updated by the study team: 2020-07-31

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age between 18 to 55 years, inclusive
Gender: all
Race/ethnicity: all races and ethnic groups
Capacity to provide informed consent
Hamilton Rating Scale for Depression (HAMD) score of ≥14 and <24, with or without symptoms of anxiety
Treatment naïve or on a stable standard antidepressant regimen (including selective serotonin reuptake inhibitors (SSRIs), serotonin-noradrenaline reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MOAIs) or tricyclic's (TCAs)) with no change in treatment 6-weeks prior to and during the tDCS intervention
Live within traveling distance to the University of California, Los Angeles (UCLA)

You may not qualify if…

Pregnancy
Non-English speaking
Current Substance Use Disorder
Neurological condition associated with brain abnormalities (e.g., traumatic brain injury; recent stroke, tumor)
Any contraindication to tDCS (e.g., skin disease or treatment causing irritation)
Any condition that would contraindicate MRI scanning (metal implants, claustrophobia or a breathing or movement disorder)
Currently receiving any form of Cognitive Behavioral Therapy, Dialectical Behavioral Therapy, or Acceptance and Commitment Therapy
Change in antidepressant medication within 6-weeks of starting the trial
Severe or treatment resistant depression - HAMD scores > 24 and a history of a major depressive episode lasting >2-years or failure to 2 or more antidepressant trials in the current index episode
Any neuromodulation therapy (e.g., ECT, transcranial magnetic stimulation (rTMS), tDCS) within the last 3-months
Current or past (within the last 1-month) use of anticonvulsants, lithium, psychostimulant, dexamphetamine
Current use of decongestants or other medication including sleeping aids previously shown to interfere with cortical excitability
Schizophrenia Axis I disorder
Dementia of any type
Bipolar I disorder
Diagnosis of seizure disorder or history of seizures
Depression related to serious medical illness (i.e., mood disorder due to general medical condition)
Actively suicidal as defined by a score of 4 on item 3 of HAMD

Where it is running

University of California, Los Angeles (UCLA) — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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