Investigating tDCS as a Treatment for Unipolar and Bipolar Depression

Bipolar Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01562184
• Other study ID #: HC11515
• Secondary ID: #11T-005
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 21, 2012
• Last updated: November 30, 2015
• Start date: June 2012
• Est. completion date: October 2015

Study information

• Verified date: November 2015
• Source: The University of New South Wales
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics CommitteeAustralia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder
• Unipolar Depression

Intervention

Device:
• Sham tDCS device
Sham tDCS
• Soterix tDCS device
Active tDCS

Locations

Country	Name	City	State
Australia	University of New South Wales / Black Dog Institute	Sydney	New South Wales
United States	Emory University	Atlanta	Georgia
United States	Rowan University	Cherry Hill	New Jersey
United States	University of Texas Southwestern	Dallas	Texas
United States	Duke University	Durham	North Carolina
United States	Sheppard Pratt	Towson	Maryland

Sponsors (6)

Lead Sponsor	Collaborator
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

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montgomery Asberg Depression Rating Scale for Depression (MADRS)		12 weeks	No
Secondary	Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)		12 weeks	No
Secondary	Montreal Cognitive Assessment (MoCA): Global Cognitive Function		8 weeks	No

External Links

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