Clinical trial NCT01562184: Investigating tDCS as a Treatment for Unipolar and Bipolar Depression
Official title: A Controlled Trial of Transcranial Direct Current Stimulation as a Treatment for Unipolar and Bipolar Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Unipolar Depression
Bipolar Depression
Lead sponsor: The University of New South Wales
Sponsor class: OTHER
Collaborators: name: Duke University
name: Emory University
name: Sheppard Pratt Health System
name: University of Medicine and Dentistry of New Jersey
name: University of Texas
First posted: 2012-03-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Montgomery Asberg Depression Rating Scale for Depression (MADRS)
timeFrame: 12 weeks
Secondary outcomes:
measure: Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)
timeFrame: 12 weeks
measure: Montreal Cognitive Assessment (MoCA): Global Cognitive Function
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Towson
country: United States
facility: Sheppard Pratt
state: Maryland
city: Cherry Hill
country: United States
facility: Rowan University
state: New Jersey
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
city: Sydney
country: Australia
facility: University of New South Wales / Black Dog Institute
state: New South Wales
Study officials:
References:
citation: Martin DM, McClintock SM, Aaronson ST, Alonzo A, Husain MM, Lisanby SH, McDonald WM, Mohan A, Nikolin S, O'Reardon J, Weickert CS, Loo CK. Pre-treatment attentional processing speed and antidepressant response to transcranial direct current stimulation: Results from an international randomized controlled trial. Brain Stimul. 2018 Nov-Dec;11(6):1282-1290. doi: 10.1016/j.brs.2018.08.011. Epub 2018 Aug 23.
citation: Loo CK, Husain MM, McDonald WM, Aaronson S, O'Reardon JP, Alonzo A, Weickert CS, Martin DM, McClintock SM, Mohan A, Lisanby SH; International Consortium of Research in tDCS (ICRT). International randomized-controlled trial of transcranial Direct Current Stimulation in depression. Brain Stimul. 2018 Jan-Feb;11(1):125-133. doi: 10.1016/j.brs.2017.10.011. Epub 2017 Oct 27.