Open Pilot Trial of TES for Depression

NCT01201148 | Completed Phase 2 DMC

• 1 other identifier: 10231
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate whether using oscillating TES (random noise stimulation) or intermittent tDCS will have greater antidepressant effects in depressed subjects, compared to standard tDCS.

Conditions

Major Depression

Keywords

depression; transcranial direct current stimulation (tDCS); random noise stimulation; oscillatory tDCS; intermittent tDCS

Outcome Measures

Primary Outcomes (1)

• Montgomery Asberg Depression Rating Scale for Depression (MADRS)

  6 months

Study Arms (1)

Oscillating or intermittent tDCS

EXPERIMENTAL

Device: tDCS (Eldith DC-Stimulator (CE certified))

Interventions

tDCS (Eldith DC-Stimulator (CE certified)) DEVICE

For participants receiving intermittent tDCS or oscillating TES, one electrode will be placed over the left pF3 electrode site (overlying the left dorsolateral prefrontal cortex and identified on the scalp using an EEG cap based on the 10/20 system) and the other over the right temporal area.

Oscillating or intermittent tDCS

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject meets criteria for a DSM-IV Major Depressive episode.

You may not qualify if:

• Diagnosis (as defined by DSM-IV) of: any psychotic disorder (lifetime); bipolar disorder; eating disorder (current or within the past year); obsessive compulsive disorder (lifetime); post-traumatic stress disorder (current or within the past year); mental retardation.
• Subject has not responded adequately to standard tDCS or is not appropriate for trial of standard tDCS (eg depression too chronic in duration)
• Total MADRS depression score of 20 or more
• History of drug or alcohol abuse or dependence (as per DSM-IV criteria) within the last 3 months (except nicotine and caffeine).
• Inadequate response to ECT in the current episode of depression.
• Subject is on regular benzodiazepine medication which it is not clinically appropriate to discontinue.
• Subject requires a rapid clinical response due to inanition, psychosis or high suicide risk.
• Neurological disorder or insult, e.g., recent stroke (CVA), which places subject at risk of seizure or neuronal damage with TES.
• Subject has metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
• Female subject who is pregnant. However, women of child bearing age are eligible if they have the pregnancy test but will be excluded if they are sexually active and not using reliable contraception (urine test for pregnancy will be used if appropriate).

Sponsors & Collaborators

• The University of New South Wales: lead

Study Sites (1)

Black Dog Institute

Sydney, New South Wales, 2031, Australia

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Colleen Loo, MBBS

  School of Psychiatry, University of New South Wales

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 8, 2010
• First Posted: September 14, 2010
• Study Start: September 1, 2010
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: December 2, 2015

Record last verified: 2015-11

Locations

AU (1)