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CompletedNCT02116127Updated Jul 31, 2017

Transcranial Direct Current Stimulation (tDCS) for Depression in Pregnancy: A Pilot Study

An interventional study of Active tDCS and Sham tDCS in Depression and Pregnancy, sponsored by Women's College Hospital. Completed at 2 sites in Canada. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-07-31.

Sponsored by Women's College Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the detailed description

Major depression is a serious condition that affects up to 10% of pregnant women, and has serious impact on the developing fetus. However current treatments are less than ideal for women with moderate to severe depression. Psychotherapy alone is either ineffective, or takes months to improve symptoms, leaving the fetus susceptible to depression during that time. Antidepressant medication is effective, but there are high refusal rates of standard pharmacological treatment because of fears about medication exposure. The highly negative impacts of depression in pregnancy on the developing fetus and child illustrate the need for evaluation of timely and innovative treatments.

Transcranial direct current stimulation (tDCS) is a non-drug treatment for depression where the dorsolateral prefrontal cortex, a part of the brain that functions abnormally when an individual is depressed, can be directly stimulated without impacting any other parts of the body or brain. As such, it is an ideal treatment for pregnant women who do not want to expose their fetus to the impact of medication treatment for depression. It has been shown to be effective in depression among non-pregnant adults and improvement is seen rapidly with a 3-week treatment course, almost 3 times faster than standard psychological treatment. There are no known serious adverse effects and no theoretical risk to a fetus.

This research study will measure the feasibility, acceptability and compliance of the tDCS as a treatment option for depression in pregnancy. In addition, the study will investigate the effect of tDCS on reducing depressive symptoms immediately post-treatment among women who have moderate to severe depression in pregnancy.

In this multi-centre, pilot randomized controlled trial, adult women with moderate to severe depression in pregnancy will be recruited from one hospital obstetrical group and two specialty perinatal mental health clinics over the course of 1 year. Women will have been offered to start or continue SSRI (Selective Serotonin Reuptake Inhibitors) or SNRI (Selective Serotonin-Norepinephrine Reuptake Inhibitors)medication but declined use. All participants will continue to receive clinical care from their respective clinical programs during the trial. Although this care may include psychotherapeutic intervention that is initiated prior to completion of the active tDCS treatment phase (if clinic psychotherapy waitlist is short), we would not expect to see improvement within the first 3 weeks of psychotherapeutic treatment. As such, this is an ideal opportunity to evaluate the efficacy of a new treatment, without depriving women of non-pharmacological standard care.

Following informed consent procedures, participants will be randomized to tDCS or a sham-control condition (1:1) with on-site treatments 5 days per week over 3 weeks in 30 minute sessions. 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 by a specially developed, battery driven constant current stimulator. The electrodes will be placed over F3 and F4 according to the international system for EEG (Electroencephalogram) placement. Sham stimulation will be administered using the same stimulation parameters and at the site of active treatment, but the current will be turned off after 30 seconds.

Women will be interviewed at baseline and then followed during treatment, every four weeks until delivery, and at four and twelve weeks postpartum to allow for measurement of depressive symptoms, pregnancy, delivery, neonatal and infant outcomes. Although baseline and treatment interviews will be conducted in person, post-treatment and post-delivery interviews will be offered in person or over the telephone, according to participant preference.

02

Conditions studied

  • Depression
  • Pregnancy

Keywords

  • Depression
  • Pregnancy
  • Transcranial Direct Current Stimulation
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 20 is below the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Women's College Hospital is the lead sponsor of 83 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  1. Pregnant women aged > 18 years
  2. >12 weeks gestation at enrollment
  3. 32 or fewer weeks gestation at first treatment visit (to increase likelihood of all treatment occurring during pregnancy)
  4. 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 ).
  5. Safe for outpatient psychiatric treatment (as assessed by Study PI).
  6. Offered, but declined to use an anti-depressant medication
  7. Capable to consent to treatment
  8. Able to understand study explanations and have questionnaires administered in English

Exclusion criteria

Exclusion Criteria:

  1. DSM-V history of alcohol and/or substance use or dependence in the previous 6 months
  2. Concomitant major and unstable medical or neurologic illness or history of seizure
  3. Currently taking carbamazepine (which may interfere with the effects of anodal tDCS),
  4. Major complications and/or a known fetal anomaly in the current pregnancy as determined by the investigator team
  5. Planning to leave Toronto prior to delivery in the current pregnancy.
  6. Metal implant(s) in cranium
  7. Electrical implant(s) in body
  8. Currently taking benzodiazepines daily (Intermittent PRN use of low-dose Lorazepam allowed)
  9. Non-intact skin on scalp areas where stimulation electrodes will be placed
  10. History of very preterm delivery in previous pregnancy (\< 32 weeks gestation)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Active tDCS

    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 comparator
    Sham tDCS

    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

  • DeviceActive tDCS

    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.

  • DeviceSham tDCS

    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.

06

What researchers measure

Primary outcomes

  1. Number of participants recruited over 1 year

    Feasibility

    Time frame: Up to one year from when the study starts enrolling participants

Secondary outcomes

  1. Montgomery Asberg Depression Rating Scale

    Efficacy - Depression Symptom Measurement

    Time frame: End of week 1

  2. Edinburgh Postnatal Depression Scale

    Efficacy - Depression Symptom Measurement

    Time frame: End of Week 1

  3. Pregnancy Experience Scale

    Efficacy - Secondary Symptom Measurement

    Time frame: End of Week 1

  4. State-Trait Anxiety Inventory

    Efficacy - Secondary Symptom Measurement

    Time frame: End of week 1

  5. Itemized neonatal health outcomes questionnaire

    Neonatal outcome (safety)

    Time frame: 4 weeks postpartum

  6. Itemized neonatal health outcomes questionnaire

    Neonatal Outcome (safety)

    Time frame: 12 weeks postpartum

  7. Bates Infant Characteristics Questionnaire

    Infant outcome (temperament)

    Time frame: 12 weeks postpartum

  8. Ages and Stages Questionnaire

    Infant outcome (development)

    Time frame: 12 weeks postpartum

  9. Toronto Side Effects Scale

    Acceptability - side effects

    Time frame: End of Week 1

  10. Toronto Side Effects Scale

    Acceptability - side effects

    Time frame: End of week 2

  11. Toronto Side Effects Scale

    Acceptability - side effects

    Time frame: End of intervention phase (end of week 3)

  12. Itemized treatment acceptability questionnaire

    Acceptability - barriers and facilitators of attending appointments

    Time frame: End of intervention phase (end of week 3)

  13. Pregnancy Complications Itemized Questionnaire

    Time frame: End of week 1

  14. Pregnancy Complications Itemized Questionnaire

    Time frame: End of week 2

  15. Pregnancy Complications Itemized Questionnaire

    Time frame: End of intervention phase (end of week 3)

  16. Pregnancy Complications Itemized Questionnaire

    Time frame: Every 4 weeks until delivery of baby (up to 26 weeks from initial randomization)

  17. Pregnancy Complications Itemized Questionnaire

    Time frame: 4 weeks postpartum

  18. Rate of follow-up data collection

    Time frame: 12 weeks postpartum

  19. Completion of all 15 treatment sessions

    Time frame: End of intervention phase (end of week 3)

  20. Treatment allocation questionnaire

    Time frame: End of week 1

  21. Treatment allocation questionnaire

    Time frame: End of intervention phase (end of week 3)

  22. Montgomery Asberg Depression Rating Scale

    Efficacy - Depression Symptom Measurement

    Time frame: End of week 2

  23. Edinburgh Postnatal Depression Scale

    Efficacy - Depression Symptom Measurement

    Time frame: End of Week 2

  24. Montgomery Asberg Depression Rating Scale

    Efficacy - Depression Symptom Measurement

    Time frame: End of intervention phase (End of week 3)

  25. Montgomery Asberg Depression Rating Scale

    Efficacy - Depression Symptom Measurement

    Time frame: Every 4 weeks until delivery (i.e. up to 26 weeks from initial randomization)

  26. Montgomery Asberg Depression Rating Scale

    Efficacy - Depression Symptom Measurement

    Time frame: 4 weeks postpartum

  27. Montgomery Asberg Depression Rating Scale

    Efficacy - Depression Symptom Measurement

    Time frame: 12 weeks postpartum

  28. Edinburgh Postnatal Depression Scale

    Efficacy - Depression Symptom Measurement

    Time frame: End of intervention phase (Week 3)

  29. Edinburgh Postnatal Depression Scale

    Efficacy - Depression Symptom Measurement

    Time frame: Every 4 weeks until delivery (i.e. up to 26 weeks from initial randomization)

  30. Edinburgh Postnatal Depression Scale

    Efficacy - Depression Symptom Measurement

    Time frame: 4 weeks postpartum

  31. Edinburgh Postnatal Depression Scale

    Efficacy - Depression Symptom Measurement

    Time frame: 12 weeks postpartum

  32. Pregnancy Experience Scale

    Efficacy - Secondary Symptom Measurement

    Time frame: End of Week 2

  33. Pregnancy Experience Scale

    Efficacy - Secondary Symptom Measurement

    Time frame: End of intervention phase (Week 3)

  34. Pregnancy Experience Scale

    Efficacy - Secondary Symptom Measurement

    Time frame: Every 4 weeks until delivery (i.e. up to 26 weeks from initial randomization)

  35. State-Trait Anxiety Inventory

    Efficacy - Secondary Symptom Measurement

    Time frame: End of week 2

  36. State-Trait Anxiety Inventory

    Efficacy - Secondary Symptom Measurement

    Time frame: End of intervention phase (end of week 3)

  37. State-Trait Anxiety Inventory

    Efficacy - Secondary Symptom Measurement

    Time frame: Every 4 weeks until delivery (i.e. up to 26 weeks from initial randomization)

  38. State-Trait Anxiety Inventory

    Efficacy - Secondary Symptom Measurement

    Time frame: 4 weeks postpartum

  39. State-Trait Anxiety Inventory

    Efficacy - Secondary Symptom Measurement

    Time frame: 12 weeks postpartum

07

Study locations

2 sites
  • Mount Sinai Hospital
    Toronto, Ontario M5G 1X5, Canada
  • Women's College Hospital
    Toronto, Ontario M5S 1B2, Canada
08

References and documents

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09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02116127
Lead sponsor
Women's College Hospital
Collaborators
Mount Sinai Hospital, Canada, Centre for Addiction and Mental Health
Responsible party
Sponsor
First posted
Apr 16, 2014
Start date
Apr 2014
Primary completion
Jul 2017
Completion
Jul 2017
Last update
Jul 31, 2017

Study contacts

Simone N Vigod, MD, MSc
principal investigator · Women's College Hospital
Daniel M Blumberger, MD, MSc
principal investigator · Centre for Addiction and Mental Health

Oversight

Data monitoring committee
No
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