NCT01792414

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 13, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 2, 2017

Status Verified

February 1, 2017

Enrollment Period

3.9 years

First QC Date

February 13, 2013

Last Update Submit

February 1, 2017

Conditions

Major Depression

Outcome Measures

Primary Outcomes (1)

  • Montgomery Asberg Depression Rating Scale for Depression (MADRS)

    12 weeks

Secondary Outcomes (1)

  • Beck Depression Inventory II

    12 weeks

Study Arms (2)

Active TES

ACTIVE COMPARATOR

Active TES

Device: Active TES

Sham TES

SHAM COMPARATOR

Sham TES

Device: Sham TES

Interventions

Sham TESDEVICE

Neuroconn Eldith device

Sham TES
Active TESDEVICE

Neuroconn Eldith device

Active TES

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Black Dog Institute / University of New South Wales

Sydney, New South Wales, 2031, Australia

Location

Related Publications (1)

  • Nikolin S, Alonzo A, Martin D, Galvez V, Buten S, Taylor R, Goldstein J, Oxley C, Hadzi-Pavlovic D, Loo CK. Transcranial Random Noise Stimulation for the Acute Treatment of Depression: A Randomized Controlled Trial. Int J Neuropsychopharmacol. 2020 Apr 21;23(3):146-156. doi: 10.1093/ijnp/pyz072.

    PMID: 31899509DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 13, 2013

First Posted

February 15, 2013

Study Start

January 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

February 2, 2017

Record last verified: 2017-02

Locations

AU(1)