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

T

The University of New South Wales

Status

Completed

Conditions

Major Depression

Treatments

Device: Sham TES
Device: Active TES

Study type

Interventional

Funder types

Other

Identifiers

NCT01792414
HC12143

Details and patient eligibility

About

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

Enrollment

70 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

70 participants in 2 patient groups

Active TES
Active Comparator group
Description:
Active TES
Treatment:
Device: Active TES
Sham TES
Sham Comparator group
Description:
Sham TES
Treatment:
Device: Sham TES

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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