Transcranial Direct Current Stimulation (tDCS) and Cognitive Task in Depression

NCT02296437 | Unknown Early Phase 1

• 1 other identifier: HC14216
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Among antidepressant treatments, electroconvulsive therapy (ECT) remains the most effective. However, patient concerns with cognitive side effects have encouraged trials of new, non-convulsive forms of mild brain stimulation such as transcranial Direct Current Stimulation (tDCS). Our past and present studies of tDCS suggest that it has antidepressant effects and is safe, painless and well tolerated. However, not all patients may have an adequate response, raising the need to find ways of optimising efficacy. This clinical pilot study will examine the feasibility and safety of combining tDCS with a cognitive training task which engages the same brain region targeted by tDCS for treatment of depression.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• Montgomery and Asberg Depression Rating Scale (MADRS)

  6 weeks

Study Arms (1)

tDCS + CT

EXPERIMENTAL

Other: Transcranial direct current stimulation combined with cognitive training

Interventions

Transcranial direct current stimulation combined with cognitive training OTHER

tDCS + CT

Eligibility Criteria

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

You may qualify if:

• Participants are aged 18-65 years.
• Participant meets criteria for a DSM-V Major Depressive episode. Criteria are as follows: Five or more symptoms present during the same 2-week period, including either 1 or 2: 1) depressed mood, 2) loss of interest or pleasure, 3) significant weight loss or gain, 4) insomnia or hypersomnia, 5) psychomotor agitation or retardation, 6) fatigue or loss of energy, 7) feelings of worthlessness or excessive or inappropriate guilt, 8) diminished ability to think concentrate or make decisions, and 9) recurrent thoughts of death, recurrent suicidal ideation, suicide attempt or plan.
• MADRS score of 20 or more.
• Right handed
• A history of non-response to ≥ 2 adequate trials of antidepressant medication treatment.

You may not qualify if:

• DSM-V psychotic disorder.
• Drug or alcohol abuse or dependence (preceding 6 months).
• Inadequate response to ECT (current episode of depression).
• Regular benzodiazepine medication
• Rapid clinical response required, e.g., due to 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.

Sponsors & Collaborators

• The University of New South Wales: lead
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (1)

University of New South Wales

Sydney, New South Wales, 2031, Australia

RECRUITING

MeSH Terms

Conditions

Depression

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Donel Martin, PhD

CONTACT

61 2 9382 8353; donel.martin@unsw.edu.au

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant

Study Record Dates

• First Submitted: November 18, 2014
• First Posted: November 20, 2014
• Study Start: November 1, 2014
• Primary Completion: November 1, 2019
• Last Updated: October 17, 2017

Record last verified: 2017-10

Locations

AU (1)