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OpenTrials
Completed

NCT Number: NCT01562184

Investigating tDCS as a Treatment for Unipolar and Bipolar Depression

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of New South Wales / Black Dog Institute, Sydney, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sham tDCS device

Device

Sham tDCS

Soterix tDCS device

Device

Active tDCS

Primary outcomes

  1. Montgomery Asberg Depression Rating Scale for Depression (MADRS)

    Time frame: 12 weeks

Secondary outcomes

  1. Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)

    Time frame: 12 weeks

  2. Montreal Cognitive Assessment (MoCA): Global Cognitive Function

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

The University of New South Wales

Other

Collaborators

  • Duke University
  • Emory University
  • Sheppard Pratt Health System
  • University of Medicine and Dentistry of New Jersey
  • University of Texas

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Mar 23, 2012
Registry last updated
Dec 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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