Open Pilot Trial of TES for Depression
This study is currently recruiting participants.
Verified February 2013 by The University of New South Wales
Sponsor:
The University of New South Wales
Information provided by (Responsible Party):
Colleen Loo, The University of New South Wales
ClinicalTrials.gov Identifier:
NCT01201148
First received: September 8, 2010
Last updated: February 3, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depression |
Device: tDCS (Eldith DC-Stimulator (CE certified)) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Study of Transcranial Electrical Stimulation (TES) for the Treatment of Depression |
Resource links provided by NLM:
Further study details as provided by The University of New South Wales:
Primary Outcome Measures:
- Montgomery Asberg Depression Rating Scale for Depression (MADRS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | September 2015 |
| Estimated Primary Completion Date: | September 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Oscillating or intermittent tDCS |
Device: tDCS (Eldith DC-Stimulator (CE certified))
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subject meets criteria for a DSM-IV Major Depressive episode.
Exclusion Criteria:
- 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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01201148
Contacts
| Contact: Angelo Alonzo, PhD | 61-2-93823720 | a.alonzo@unsw.edu.au |
| Contact: Donel Martin, PhD | 61-2-93829261 | donel.martin@unsw.edu.au |
Locations
| Australia, New South Wales | |
| Black Dog Institute | Recruiting |
| Sydney, New South Wales, Australia, 2031 | |
| Contact: Angelo Alonzo, PhD 61-2-93823720 a.alonzo@unsw.edu.au | |
| Contact: Donel Martin, PhD 61-2-93829261 donel.martin@unsw.edu.au | |
| Principal Investigator: Colleen Loo, MBBS | |
Sponsors and Collaborators
The University of New South Wales
Investigators
| Principal Investigator: | Colleen Loo, MBBS | School of Psychiatry, University of New South Wales |
More Information
No publications provided
| Responsible Party: | Colleen Loo, Professor, The University of New South Wales |
| ClinicalTrials.gov Identifier: | NCT01201148 History of Changes |
| Other Study ID Numbers: | 10231 |
| Study First Received: | September 8, 2010 |
| Last Updated: | February 3, 2013 |
| Health Authority: | Australia: Human Research Ethics Committee Australia: Department of Health and Ageing Therapeutic Goods Administration |
Keywords provided by The University of New South Wales:
|
depression transcranial direct current stimulation (tDCS) random noise stimulation oscillatory tDCS intermittent tDCS |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Depressive Disorder, Major |
Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on June 17, 2013