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DepressionNCT02116127

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

A study testing Active tDCS in people with Depression and Pregnancy, run by Women's College Hospital at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Depression, Pregnancy
What is being tested?
Active tDCS
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
2 sitesCanada
Study dates
Apr 2014to Jul 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pregnant women aged > 18 years
  • >12 weeks gestation at enrollment
  • 32 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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)

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • Mount Sinai Hospital

    Toronto, Ontario, M5G 1X5

  • Women's College Hospital

    Toronto, Ontario, M5S 1B2

Other trials in Canada

About this study

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.

Being tested
Active tDCS, Sham tDCS
Keywords
Depression, Pregnancy, Transcranial Direct Current Stimulation
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

Study groups in NCT02116127
Study groupRoleWhat they receive
Active tDCSExperimentalThe 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.
Receives: Device: Active tDCS
Sham tDCSSham comparatorThe 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.
Receives: Device: Sham tDCS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants recruited over 1 year

    Feasibility

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

Secondary outcomes (39)

  1. Montgomery Asberg Depression Rating Scale

    Efficacy - Depression Symptom Measurement

    Measured: End of week 1

  2. Edinburgh Postnatal Depression Scale

    Efficacy - Depression Symptom Measurement

    Measured: End of Week 1

  3. Pregnancy Experience Scale

    Efficacy - Secondary Symptom Measurement

    Measured: End of Week 1

  4. State-Trait Anxiety Inventory

    Efficacy - Secondary Symptom Measurement

    Measured: End of week 1

  5. Itemized neonatal health outcomes questionnaire

    Neonatal outcome (safety)

    Measured: 4 weeks postpartum

  6. Itemized neonatal health outcomes questionnaire

    Neonatal Outcome (safety)

    Measured: 12 weeks postpartum

  7. Bates Infant Characteristics Questionnaire

    Infant outcome (temperament)

    Measured: 12 weeks postpartum

  8. Ages and Stages Questionnaire

    Infant outcome (development)

    Measured: 12 weeks postpartum

  9. Toronto Side Effects Scale

    Acceptability - side effects

    Measured: End of Week 1

  10. Toronto Side Effects Scale

    Acceptability - side effects

    Measured: End of week 2

  11. Toronto Side Effects Scale

    Acceptability - side effects

    Measured: End of intervention phase (end of week 3)

  12. Itemized treatment acceptability questionnaire

    Acceptability - barriers and facilitators of attending appointments

    Measured: End of intervention phase (end of week 3)

  13. Pregnancy Complications Itemized Questionnaire

    Measured: End of week 1

  14. Pregnancy Complications Itemized Questionnaire

    Measured: End of week 2

  15. Pregnancy Complications Itemized Questionnaire

    Measured: End of intervention phase (end of week 3)

  16. Pregnancy Complications Itemized Questionnaire

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

  17. Pregnancy Complications Itemized Questionnaire

    Measured: 4 weeks postpartum

  18. Rate of follow-up data collection

    Measured: 12 weeks postpartum

  19. Completion of all 15 treatment sessions

    Measured: End of intervention phase (end of week 3)

  20. Treatment allocation questionnaire

    Measured: End of week 1

  21. Treatment allocation questionnaire

    Measured: End of intervention phase (end of week 3)

  22. Montgomery Asberg Depression Rating Scale

    Efficacy - Depression Symptom Measurement

    Measured: End of week 2

  23. Edinburgh Postnatal Depression Scale

    Efficacy - Depression Symptom Measurement

    Measured: End of Week 2

  24. Montgomery Asberg Depression Rating Scale

    Efficacy - Depression Symptom Measurement

    Measured: End of intervention phase (End of week 3)

  25. Montgomery Asberg Depression Rating Scale

    Efficacy - Depression Symptom Measurement

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

  26. Montgomery Asberg Depression Rating Scale

    Efficacy - Depression Symptom Measurement

    Measured: 4 weeks postpartum

  27. Montgomery Asberg Depression Rating Scale

    Efficacy - Depression Symptom Measurement

    Measured: 12 weeks postpartum

  28. Edinburgh Postnatal Depression Scale

    Efficacy - Depression Symptom Measurement

    Measured: End of intervention phase (Week 3)

  29. Edinburgh Postnatal Depression Scale

    Efficacy - Depression Symptom Measurement

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

  30. Edinburgh Postnatal Depression Scale

    Efficacy - Depression Symptom Measurement

    Measured: 4 weeks postpartum

  31. Edinburgh Postnatal Depression Scale

    Efficacy - Depression Symptom Measurement

    Measured: 12 weeks postpartum

  32. Pregnancy Experience Scale

    Efficacy - Secondary Symptom Measurement

    Measured: End of Week 2

  33. Pregnancy Experience Scale

    Efficacy - Secondary Symptom Measurement

    Measured: End of intervention phase (Week 3)

  34. Pregnancy Experience Scale

    Efficacy - Secondary Symptom Measurement

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

  35. State-Trait Anxiety Inventory

    Efficacy - Secondary Symptom Measurement

    Measured: End of week 2

  36. State-Trait Anxiety Inventory

    Efficacy - Secondary Symptom Measurement

    Measured: End of intervention phase (end of week 3)

  37. State-Trait Anxiety Inventory

    Efficacy - Secondary Symptom Measurement

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

  38. State-Trait Anxiety Inventory

    Efficacy - Secondary Symptom Measurement

    Measured: 4 weeks postpartum

  39. State-Trait Anxiety Inventory

    Efficacy - Secondary Symptom Measurement

    Measured: 12 weeks postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionJul 2017
  4. Study completionJul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02116127
Sponsor's protocol ID
NI14-020
Status last verified
Jul 2017
First submitted
2 Apr 2014
Last updated
31 Jul 2017
Results posted
No
Data monitoring committee
No

Publications

  • Bates JE, Freeland CA, Lounsbury ML. Measurement of infant difficultness. Child Dev. 1979 Sep;50(3):794-803.

    PubMed 498854

  • Steer RA, Scholl TO, Hediger ML, Fischer RL. Self-reported depression and negative pregnancy outcomes. J Clin Epidemiol. 1992 Oct;45(10):1093-9. doi: 10.1016/0895-4356(92)90149-h.

    PubMed 1474405

  • Murray L. The impact of postnatal depression on infant development. J Child Psychol Psychiatry. 1992 Mar;33(3):543-61. doi: 10.1111/j.1469-7610.1992.tb00890.x.

    PubMed 1577898

  • Zuckerman B, Bauchner H, Parker S, Cabral H. Maternal depressive symptoms during pregnancy, and newborn irritability. J Dev Behav Pediatr. 1990 Aug;11(4):190-4.

    PubMed 2212032

  • Williams JB. A structured interview guide for the Hamilton Depression Rating Scale. Arch Gen Psychiatry. 1988 Aug;45(8):742-7. doi: 10.1001/archpsyc.1988.01800320058007.

    PubMed 3395203

  • Sandman CA, Wadhwa PD, Dunkel-Schetter C, Chicz-DeMet A, Belman J, Porto M, Murata Y, Garite TJ, Crinella FM. Psychobiological influences of stress and HPA regulation on the human fetus and infant birth outcomes. Ann N Y Acad Sci. 1994 Oct 31;739:198-210. doi: 10.1111/j.1749-6632.1994.tb19822.x. No abstract available.

    PubMed 7832474

  • Pastuszak A, Schick-Boschetto B, Zuber C, Feldkamp M, Pinelli M, Sihn S, Donnenfeld A, McCormack M, Leen-Mitchell M, Woodland C, et al. Pregnancy outcome following first-trimester exposure to fluoxetine (Prozac). JAMA. 1993 May 5;269(17):2246-8.

    PubMed 8474204

  • Orr ST, Miller CA. Maternal depressive symptoms and the risk of poor pregnancy outcome. Review of the literature and preliminary findings. Epidemiol Rev. 1995;17(1):165-71. doi: 10.1093/oxfordjournals.epirev.a036172. No abstract available.

    PubMed 8521934

  • Chambers CD, Johnson KA, Dick LM, Felix RJ, Jones KL. Birth outcomes in pregnant women taking fluoxetine. N Engl J Med. 1996 Oct 3;335(14):1010-5. doi: 10.1056/NEJM199610033351402.

    PubMed 8793924

  • Kulin NA, Pastuszak A, Sage SR, Schick-Boschetto B, Spivey G, Feldkamp M, Ormond K, Matsui D, Stein-Schechman AK, Cook L, Brochu J, Rieder M, Koren G. Pregnancy outcome following maternal use of the new selective serotonin reuptake inhibitors: a prospective controlled multicenter study. JAMA. 1998 Feb 25;279(8):609-10. doi: 10.1001/jama.279.8.609.

    PubMed 9486756

  • Beck CT. The effects of postpartum depression on child development: a meta-analysis. Arch Psychiatr Nurs. 1998 Feb;12(1):12-20. doi: 10.1016/s0883-9417(98)80004-6.

    PubMed 9489170

  • Sinclair D, Murray L. Effects of postnatal depression on children's adjustment to school. Teacher's reports. Br J Psychiatry. 1998 Jan;172:58-63. doi: 10.1192/bjp.172.1.58.

    PubMed 9534834

  • Weinberg MK, Tronick EZ. The impact of maternal psychiatric illness on infant development. J Clin Psychiatry. 1998;59 Suppl 2:53-61.

    PubMed 9559760

  • Judd LL, Akiskal HS, Maser JD, Zeller PJ, Endicott J, Coryell W, Paulus MP, Kunovac JL, Leon AC, Mueller TI, Rice JA, Keller MB. A prospective 12-year study of subsyndromal and syndromal depressive symptoms in unipolar major depressive disorders. Arch Gen Psychiatry. 1998 Aug;55(8):694-700. doi: 10.1001/archpsyc.55.8.694.

    PubMed 9707379

  • Teixeira JM, Fisk NM, Glover V. Association between maternal anxiety in pregnancy and increased uterine artery resistance index: cohort based study. BMJ. 1999 Jan 16;318(7177):153-7. doi: 10.1136/bmj.318.7177.153.

    PubMed 9888905

Questions about this trial

What is this clinical trial studying?

A study testing Active tDCS in people with Depression and Pregnancy, run by Women's College Hospital at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants recruited over 1 year (time frame: Up to one year from when the study starts enrolling participants). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02116127, which also lists 111 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2017.

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