Investigating tDCS as a Treatment for Unipolar and Bipolar Depression

• Sponsor: The University of New South Wales (Other)
• Overall Status: Completed
• CT.gov ID: NCT01562184
• Collaborator: Duke University (Other), Emory University (Other), Sheppard Pratt Health System (Other), University of Medicine and Dentistry of New Jersey (Other), University of Texas (Other)
• Enrollment: 120
• Locations: 6
• Arms: 2
• Duration (Months): 40
• Patients Per Site: 20
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Unipolar Depression; Bipolar Depression	Device: Sham tDCS device; Device: Soterix tDCS device	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Controlled Trial of Transcranial Direct Current Stimulation as a Treatment for Unipolar and Bipolar Depression
• Study Start Date: Jun 1, 2012
• Actual Primary Completion Date: Oct 1, 2015
• Actual Study Completion Date: Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Active tDCS Active tDCS	Device: Soterix tDCS device; Active tDCS
Sham Comparator: Sham tDCS Sham tDCS	Device: Sham tDCS device; Sham tDCS

Outcome Measures

Primary Outcome Measures

1. Montgomery Asberg Depression Rating Scale for Depression (MADRS) [12 weeks]

Secondary Outcome Measures

1. Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) [12 weeks]

2. Montreal Cognitive Assessment (MoCA): Global Cognitive Function [8 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emory University	Atlanta	Georgia	United States	30322
2	Sheppard Pratt	Towson	Maryland	United States	21285
3	Rowan University	Cherry Hill	New Jersey	United States	08002
4	Duke University	Durham	North Carolina	United States	27710
5	University of Texas Southwestern	Dallas	Texas	United States	75390
6	University of New South Wales / Black Dog Institute	Sydney	New South Wales	Australia	2031

Sponsors and Collaborators

• 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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Colleen Loo, Professor, The University of New South Wales
• ClinicalTrials.gov Identifier: NCT01562184
• Other Study ID Numbers: HC11515; #11T-005
• First Posted: Mar 23, 2012
• Last Update Posted: Dec 2, 2015
• Last Verified: Nov 1, 2015

• Additional relevant MeSH terms: Depression; Depressive Disorder; Bipolar Disorder

Study Results

No Results Posted as of Dec 2, 2015