NCT01078948

Brief Summary

The project will investigate the use of a novel neuromodulatory technique, transcranial direct current stimulation (tDCS) in the treatment of patients with major depressive disorder. Hypothesis 1: Active tDCS will improve depressive symptomology to a significantly greater degree than sham treatment. Hypothesis 2: Active tDCS will be well tolerated and free of major side effects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable major-depressive-disorder

Timeline
Completed

Started Feb 2008

Typical duration for not_applicable major-depressive-disorder

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

February 1, 2008

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2008

Completed
2 years until next milestone

First Posted

Study publicly available on registry

March 2, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

February 10, 2012

Status Verified

February 1, 2012

Enrollment Period

2.7 years

First QC Date

February 25, 2008

Last Update Submit

February 9, 2012

Conditions

Major Depressive Disorder

Keywords

tDCStranscranial direct current stimulationmajor depressiondouble-blindrandomizedplacebo-controlledtreatment

Outcome Measures

Primary Outcomes (1)

  • Hamilton Rating Scale for Depression (HAMD), 17-item version

    The Hamilton Depression Scale (HAMD) is a clinician administered test measuring the severity of depressive symptoms in adults and children.

    Baseline and at 3 weeks

Study Arms (2)

Active 2mA tDCS

EXPERIMENTAL

The stimulator will be used to deliver anodal stimulation to the left prefrontal cortex and cathodal stimulation to the right prefrontal cortex. The placement of the anode is proposed to enhance activity in the left frontal cortex; the cathode aims to reduce activity in the right prefrontal cortex.

Device: transcranial direct current stimulation (tDCS)

Sham tDCS

SHAM COMPARATOR

The system setup is identical to that of active tDCS; however, the stimulator will be turned off after 30 seconds.

Device: transcranial direct current stimulation (tDCS)

Interventions

transcranial direct current stimulation (tDCS)DEVICE

Delivery of mild current to specified brain regions.

Also known as: Stimulator CX-6650 (Rolf Schneider Electronics, Germany)
Active 2mA tDCSSham tDCS

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Competent to consent
  • Have a diagnosis of Major Depressive Disorder and are currently experiencing a Major Depressive Episode as confirmed by the SCID-IV
  • Treatment resistant, defined as a failure to achieve a clinical response, or an inability to tolerate, at least two trials of antidepressant medication of sufficient dose for at least 6 weeks
  • Aged 18 to 75.

You may not qualify if:

  • DSM-IV history of substance abuse or dependence in the last 6 months
  • A major and/or unstable medical or neurologic illness
  • Currently taking carbamazepine
  • Pregnancy
  • History of seizures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

Location

Related Publications (1)

  • Blumberger DM, Tran LC, Fitzgerald PB, Hoy KE, Daskalakis ZJ. A randomized double-blind sham-controlled study of transcranial direct current stimulation for treatment-resistant major depression. Front Psychiatry. 2012 Aug 17;3:74. doi: 10.3389/fpsyt.2012.00074. eCollection 2012.

    PMID: 22912618DERIVED

Related Links

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Jeff Daskalakis, MD, PhD

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Brain Stimulation Treatment and Research Program

Study Record Dates

First Submitted

February 25, 2008

First Posted

March 2, 2010

Study Start

February 1, 2008

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

February 10, 2012

Record last verified: 2012-02

Locations

CA(1)