Transcranial Electrical Stimulation (TES) for the Treatment of Depression.

Major Depression Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01792414
• Other study ID #: HC12143
• Status: Completed
• Phase: N/A
• First received: February 13, 2013
• Last updated: February 1, 2017
• Start date: January 2013
• Est. completion date: December 2016

Study information

• Verified date: February 2017
• Source: The University of New South Wales
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a RCT of transcranial electrical stimulation in depressed patients. Mood, cognitive test performance and biomarkers will be measured during the trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• DSM-IV Major Depressive Episode (as part of a Major Depressive Disorder or Bipolar Disorder), of minimum 4 weeks duration.

• MADRS score = 20 at study entry.

Exclusion Criteria:

• DSM-IV psychotic disorder;

• drug or alcohol abuse or dependence (preceding 12 months);

• inadequate response to ECT (current episode of depression);

• anticonvulsant or benzodiazepine medication;

• rapid clinical response required, e.g. high suicide risk; 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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression

Intervention

Device:
• Sham TES
Neuroconn Eldith device
• Active TES
Neuroconn Eldith device

Locations

Country	Name	City	State
Australia	Black Dog Institute / University of New South Wales	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
The University of New South Wales

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montgomery Asberg Depression Rating Scale for Depression (MADRS)		12 weeks
Secondary	Beck Depression Inventory II		12 weeks