NCT02212366

Brief Summary

Late Life Depression (LLD) is a serious health problem which not only causes depressed mood but also results in impairments in memory and attention. These impairments are likely to be resistant to treatment, which increases the chances of developing dementia even after successful treatment of mood.This study is a randomized controlled trial of transcranial Direct Current Stimulation (tDCS) in people with LLD to enhance their cognition after successful treatment of mood with established medications. tDCS is non invasive, relatively inexpensive and portable, and has been found to be safe.This study also serves as a pilot study to assess the effects of tDCS on cognition and neurophysiologic markers of cognition among patients with LLD. Primary study hypothesis is that participants Participants randomized to tDCS will perform better on a working memory task 2 weeks and 3 months following the tDCS course.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 8, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

January 24, 2018

Status Verified

January 1, 2018

Enrollment Period

3.5 years

First QC Date

August 6, 2014

Last Update Submit

January 22, 2018

Conditions

CognitionDepression

Keywords

TDCSDepressionBrain StimulationMemoryCognitionEEG

Outcome Measures

Primary Outcomes (1)

  • To compare performance on working memory task (N-Back) and neuropsychological battery between active and sham TDCS groups

    Two weeks following the TDCS course

Secondary Outcomes (1)

  • To compare performance on working memory task (N-Back) and neuropsychological battery between active and sham TDCS groups

    Three months following the TDCS course

Other Outcomes (2)

  • To compare theta-gamma coupling as measured by electroencephalography between active and sham TDCS groups.

    Two weeks following the TDCS

  • To compare theta-gamma coupling as measured by electroencephalography between active and sham TDCS groups.

    3 months following the TDCS

Study Arms (2)

Active TDCS

EXPERIMENTAL

2-week course of daily (5 days/week) active bilateral anodal TDCS, duration 30 minute each session. Current 2 mA.

Device: Active TDCS

Sham TDCS

SHAM COMPARATOR

2-week course of daily (5 days/week) Sham bilateral tDCS. Duration 30 minute each session.

Device: Sham TDCS

Interventions

Active TDCSDEVICE

Active Stimulation

Active TDCS
Sham TDCSDEVICE

Sham Stimulation

Sham TDCS

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women and men of any races or ethnicity
  • Age 60 and above
  • Major depressive disorder, single or recurrent per SCID DSM-IV criteria AND remission from that episode as defined by DSM IV-TR criteria for remission.
  • Montgomery-Asberg Depression Rating Scale (MADRS) score less than 10.
  • Ability to speak English fluently enough to complete all research assessments.
  • Corrected visual ability to read newspaper headlines; hearing capacity to respond to a raised conversational voice
  • Willingness and ability to provide consent

You may not qualify if:

  • DSM IV TR criteria for any dementia
  • DSM IV TR criteria for life-time bipolar disorder, schizophrenia, schizoaffective disorder, or other psychotic disorders
  • DSM IV TR criteria for any substance abuse or dependence within the past 6 months
  • Presence of psychotic features or any other symptoms that would make the participant unable to participate in the study.
  • Any medical contra-indications to tDCS.
  • Electroconvulsive therapy in the last 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Addiction and Mental Health

Toronto, Ontario, M6J1H4, Canada

Location

Related Publications (1)

  • Kumar S, Batist J, Ghazala Z, Zomorrodi RM, Brooks H, Goodman M, Blumberger DM, Daskalakis ZJ, Mulsant BH, Rajji TK. Effects of bilateral transcranial direct current stimulation on working memory and global cognition in older patients with remitted major depression: A pilot randomized clinical trial. Int J Geriatr Psychiatry. 2020 Oct;35(10):1233-1242. doi: 10.1002/gps.5361. Epub 2020 Jul 21.

    PMID: 32525222DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Tarek K Rajji, MD

    Center for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 6, 2014

First Posted

August 8, 2014

Study Start

May 1, 2014

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

January 24, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)