NCT02116127

Brief Summary

The purpose of this pilot study is to examine the feasibility of conducting a multi-site double-blind randomized controlled trial whose aim will be to evaluate the effectiveness of transcranial direct current stimulation (tDCS) for treatment in pregnant women with moderate to severe major depression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable depression

Geographic Reach
1 country

2 active sites

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

April 1, 2014

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 2, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 16, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

July 31, 2017

Status Verified

July 1, 2017

Enrollment Period

3.3 years

First QC Date

April 2, 2014

Last Update Submit

July 27, 2017

Conditions

DepressionPregnancy

Keywords

DepressionPregnancyTranscranial Direct Current Stimulation

Outcome Measures

Primary Outcomes (1)

  • Number of participants recruited over 1 year

    Feasibility

    Up to one year from when the study starts enrolling participants

Secondary Outcomes (39)

  • Montgomery Asberg Depression Rating Scale

    End of week 1

  • Edinburgh Postnatal Depression Scale

    End of Week 1

  • Pregnancy Experience Scale

    End of Week 1

  • State-Trait Anxiety Inventory

    End of week 1

  • Itemized neonatal health outcomes questionnaire

    4 weeks postpartum

  • +34 more secondary outcomes

Study Arms (2)

Active tDCS

EXPERIMENTAL

The intervention is active 2mA transcranial direct current stimulation (tDCS). Direct current will be transferred with a pair of saline soaked sponge electrodes (contact area 5 x 7cm), and delivered for 30 minutes. The electrodes will be placed over F3 and F4 according to the 10-20 international system for EEG placement.

Device: Active tDCS

Sham tDCS

SHAM COMPARATOR

The sham intervention is transcranial direct current stimulation (tDCS). 2mA of direct current will be transferred with a pair of saline soaked sponge electrodes (contact area 5 x 7cm), and the current will be turned off after 54 seconds.The electrodes will be placed over F3 and F4 according to the 10-20 international system for EEG placement.

Device: Sham tDCS

Interventions

Active tDCSDEVICE

The intervention is active 2mA transcranial direct current stimulation (tDCS). Direct current will be transferred with a pair of saline soaked sponge electrodes (contact area 5 x 7cm), and delivered for 30 minutes. The electrodes will be placed over F3 and F4 according to the 10-20 international system for EEG placement.

Active tDCS
Sham tDCSDEVICE

The sham intervention is transcranial direct current stimulation (tDCS). 2mA of direct current will be transferred with a pair of saline soaked sponge electrodes (contact area 5 x 7cm), and the current will be turned off after 54 seconds.The electrodes will be placed over F3 and F4 according to the 10-20 international system for EEG placement.

Sham tDCS

Eligibility Criteria

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

You may qualify if:

  • Pregnant women aged \> 18 years
  • \>12 weeks gestation at enrollment
  • or fewer weeks gestation at first treatment visit (to increase likelihood of all treatment occurring during pregnancy)
  • Diagnosis of Major Depressive Disorder and in a Moderate-severe major depressive episode without psychotic features (as confirmed by the Mini-International Neuropsychiatric Interview, MINI ).
  • Safe for outpatient psychiatric treatment (as assessed by Study PI).
  • Offered, but declined to use an anti-depressant medication
  • Capable to consent to treatment
  • Able to understand study explanations and have questionnaires administered in English

You may not qualify if:

  • DSM-V history of alcohol and/or substance use or dependence in the previous 6 months
  • Concomitant major and unstable medical or neurologic illness or history of seizure
  • Currently taking carbamazepine (which may interfere with the effects of anodal tDCS),
  • Major complications and/or a known fetal anomaly in the current pregnancy as determined by the investigator team
  • Planning to leave Toronto prior to delivery in the current pregnancy.
  • Metal implant(s) in cranium
  • Electrical implant(s) in body
  • Currently taking benzodiazepines daily (Intermittent PRN use of low-dose Lorazepam allowed)
  • Non-intact skin on scalp areas where stimulation electrodes will be placed
  • History of very preterm delivery in previous pregnancy (\< 32 weeks gestation)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location

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  • Vigod SN, Murphy KE, Dennis CL, Oberlander TF, Ray JG, Daskalakis ZJ, Blumberger DM. Transcranial direct current stimulation (tDCS) for depression in pregnancy: A pilot randomized controlled trial. Brain Stimul. 2019 Nov-Dec;12(6):1475-1483. doi: 10.1016/j.brs.2019.06.019. Epub 2019 Jun 19.

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MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Simone N Vigod, MD, MSc

    Women's College Hospital

    PRINCIPAL INVESTIGATOR

  • Daniel M Blumberger, MD, MSc

    Centre 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
SPONSOR

Study Record Dates

First Submitted

April 2, 2014

First Posted

April 16, 2014

Study Start

April 1, 2014

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

July 31, 2017

Record last verified: 2017-07

Locations

CA(2)