Investigating tDCS as a Treatment for Unipolar and Bipolar Depression

Study ID
HC11515

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • UT Southwestern-Other
  • Parkland Health & Hospital System

Contact


Principal Investigator

Official Title

A Controlled Trial of Transcranial Direct Current Stimulation as a Treatment for Unipolar and Bipolar Depression

Brief Overview


Transcranial direct current stimulation (tDCS) is a novel treatment approach for depression
that has shown promising efficacy in four recent double-blind, randomized, sham-controlled
trials (RCT) and a meta-analysis. This study is a RCT of tDCS in depressed patients, testing
its efficacy in both unipolar and bipolar depression. Mood, cognitive test performance and
biomarkers will be measured during the trial.

Participant Eligibility


Inclusion Criteria:

- 18 years of age or above.

- Meets criteria for a DSM-IV Major Depressive Episode with duration of at least 4
weeks.

- Total score ≥ 20 on the Montgomery-Asberg Depression Rating Scale at study entry.

Exclusion Criteria:

- Current episode duration greater than 3 years.

- Failed more than 3 adequate antidepressant trials in current episode.

- DSM-IV psychotic disorder.

- Drug or alcohol abuse or dependence (preceding 3 months).

- Inadequate response to ECT in the current episode of depression.

- Rapid clinical response required, e.g., high suicide risk.

- Significant acute suicide risk, defined as follows: suicide attempt within the
previous 6 months that required medical treatment; or ≥ 2 suicide attempts in the
past 12 months; or has a clear-cut plan for suicide and states that they cannot
guarantee that they will call their regular psychiatrist or the investigator if the
impulse to implement the plan becomes substantial during the study; or in the
investigator's opinion, is likely to attempt suicide within the next 6 months.

- Clinically defined neurological disorder or insult.

- Metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash)
at proposed electrode sites.

- Pregnancy.

- Concurrent long acting benzodiazepines, ritalin or dexamphetamine medication.