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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01792414
• Date of registration: 13/02/2013
• Prospective Registration: No
• Primary sponsor: The University of New South Wales
• Public title: Transcranial Electrical Stimulation (TES) for the Treatment of Depression.
• Date of first enrolment: January 2013
• Target sample size: 70
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01792414
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Australia

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Major Depression

Intervention(s)

Device: Active TES

Device: Sham TES

Primary Outcome(s)

Montgomery Asberg Depression Rating Scale for Depression (MADRS) [Time Frame: 12 weeks]

Secondary Outcome(s)

Beck Depression Inventory II [Time Frame: 12 weeks]

Secondary ID(s)

HC12143

Source(s) of Monetary Support

Please refer to primary and secondary sponsors