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Investigating tDCS as a Treatment for Unipolar and Bipolar Depression

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by The University of New South Wales
Sponsor:
Collaborators:
Duke University
Emory University
Sheppard Pratt Health System
University of Medicine and Dentistry of New Jersey
University of Texas
Information provided by (Responsible Party):
Colleen Loo, The University of New South Wales
ClinicalTrials.gov Identifier:
NCT01562184
First received: March 21, 2012
Last updated: August 27, 2014
Last verified: August 2014

March 21, 2012
August 27, 2014
June 2012
March 2015   (final data collection date for primary outcome measure)
Montgomery Asberg Depression Rating Scale for Depression (MADRS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01562184 on ClinicalTrials.gov Archive Site
  • Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Montreal Cognitive Assessment (MoCA): Global Cognitive Function [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Investigating tDCS as a Treatment for Unipolar and Bipolar Depression
A Controlled Trial of Transcranial Direct Current Stimulation 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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Unipolar Depression
  • Bipolar Depression
  • Device: Sham tDCS device
    Sham tDCS
  • Device: Soterix tDCS device
    Active tDCS
  • Active Comparator: Active tDCS
    Active tDCS
    Intervention: Device: Soterix tDCS device
  • Sham Comparator: Sham tDCS
    Sham tDCS
    Intervention: Device: Sham tDCS device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
Not Provided
March 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Angelo Alonzo, PhD 61-2-93823720 a.alonzo@unsw.edu.au
Contact: Donel Martin, PhD 61-2-93829261 donel.martin@unsw.edu.au
United States,   Australia
 
NCT01562184
HC11515, #11T-005
Yes
Colleen Loo, The University of New South Wales
The University of New South Wales
  • Duke University
  • Emory University
  • Sheppard Pratt Health System
  • University of Medicine and Dentistry of New Jersey
  • University of Texas
Not Provided
The University of New South Wales
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP