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

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ClinicalTrials.gov Identifier: NCT02116127
Recruitment Status : Completed
First Posted : April 16, 2014
Last Update Posted : July 31, 2017
Sponsor:
Collaborators:
Mount Sinai Hospital, Canada
Centre for Addiction and Mental Health
Information provided by (Responsible Party):
Women's College Hospital

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.

Condition or disease Intervention/treatment Phase
Depression Pregnancy Device: Active tDCS Device: Sham tDCS Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation (tDCS) for Depression in Pregnancy: A Pilot Study
Study Start Date : April 2014
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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 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
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.




Primary Outcome Measures :
  1. Number of participants recruited over 1 year [ Time Frame: Up to one year from when the study starts enrolling participants ]
    Feasibility


Secondary Outcome Measures :
  1. Montgomery Asberg Depression Rating Scale [ Time Frame: End of week 1 ]
    Efficacy - Depression Symptom Measurement

  2. Edinburgh Postnatal Depression Scale [ Time Frame: End of Week 1 ]
    Efficacy - Depression Symptom Measurement

  3. Pregnancy Experience Scale [ Time Frame: End of Week 1 ]
    Efficacy - Secondary Symptom Measurement

  4. State-Trait Anxiety Inventory [ Time Frame: End of week 1 ]
    Efficacy - Secondary Symptom Measurement

  5. Itemized neonatal health outcomes questionnaire [ Time Frame: 4 weeks postpartum ]
    Neonatal outcome (safety)

  6. Itemized neonatal health outcomes questionnaire [ Time Frame: 12 weeks postpartum ]
    Neonatal Outcome (safety)

  7. Bates Infant Characteristics Questionnaire [ Time Frame: 12 weeks postpartum ]
    Infant outcome (temperament)

  8. Ages and Stages Questionnaire [ Time Frame: 12 weeks postpartum ]
    Infant outcome (development)

  9. Toronto Side Effects Scale [ Time Frame: End of Week 1 ]
    Acceptability - side effects

  10. Toronto Side Effects Scale [ Time Frame: End of week 2 ]
    Acceptability - side effects

  11. Toronto Side Effects Scale [ Time Frame: End of intervention phase (end of week 3) ]
    Acceptability - side effects

  12. Itemized treatment acceptability questionnaire [ Time Frame: End of intervention phase (end of week 3) ]
    Acceptability - barriers and facilitators of attending appointments

  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 [ Time Frame: End of week 2 ]
    Efficacy - Depression Symptom Measurement

  23. Edinburgh Postnatal Depression Scale [ Time Frame: End of Week 2 ]
    Efficacy - Depression Symptom Measurement

  24. Montgomery Asberg Depression Rating Scale [ Time Frame: End of intervention phase (End of week 3) ]
    Efficacy - Depression Symptom Measurement

  25. Montgomery Asberg Depression Rating Scale [ Time Frame: Every 4 weeks until delivery (i.e. up to 26 weeks from initial randomization) ]
    Efficacy - Depression Symptom Measurement

  26. Montgomery Asberg Depression Rating Scale [ Time Frame: 4 weeks postpartum ]
    Efficacy - Depression Symptom Measurement

  27. Montgomery Asberg Depression Rating Scale [ Time Frame: 12 weeks postpartum ]
    Efficacy - Depression Symptom Measurement

  28. Edinburgh Postnatal Depression Scale [ Time Frame: End of intervention phase (Week 3) ]
    Efficacy - Depression Symptom Measurement

  29. Edinburgh Postnatal Depression Scale [ Time Frame: Every 4 weeks until delivery (i.e. up to 26 weeks from initial randomization) ]
    Efficacy - Depression Symptom Measurement

  30. Edinburgh Postnatal Depression Scale [ Time Frame: 4 weeks postpartum ]
    Efficacy - Depression Symptom Measurement

  31. Edinburgh Postnatal Depression Scale [ Time Frame: 12 weeks postpartum ]
    Efficacy - Depression Symptom Measurement

  32. Pregnancy Experience Scale [ Time Frame: End of Week 2 ]
    Efficacy - Secondary Symptom Measurement

  33. Pregnancy Experience Scale [ Time Frame: End of intervention phase (Week 3) ]
    Efficacy - Secondary Symptom Measurement

  34. Pregnancy Experience Scale [ Time Frame: Every 4 weeks until delivery (i.e. up to 26 weeks from initial randomization) ]
    Efficacy - Secondary Symptom Measurement

  35. State-Trait Anxiety Inventory [ Time Frame: End of week 2 ]
    Efficacy - Secondary Symptom Measurement

  36. State-Trait Anxiety Inventory [ Time Frame: End of intervention phase (end of week 3) ]
    Efficacy - Secondary Symptom Measurement

  37. State-Trait Anxiety Inventory [ Time Frame: Every 4 weeks until delivery (i.e. up to 26 weeks from initial randomization) ]
    Efficacy - Secondary Symptom Measurement

  38. State-Trait Anxiety Inventory [ Time Frame: 4 weeks postpartum ]
    Efficacy - Secondary Symptom Measurement

  39. State-Trait Anxiety Inventory [ Time Frame: 12 weeks postpartum ]
    Efficacy - Secondary Symptom Measurement



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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:

  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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02116127


Locations
Layout table for location information
Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Women's College Hospital
Toronto, Ontario, Canada, M5S 1B2
Sponsors and Collaborators
Women's College Hospital
Mount Sinai Hospital, Canada
Centre for Addiction and Mental Health
Investigators
Layout table for investigator information
Principal Investigator: Simone N Vigod, MD, MSc Women's College Hospital
Principal Investigator: Daniel M Blumberger, MD, MSc Centre for Addiction and Mental Health

Publications:
World Health Organization. (WHO). Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products. WHO Technical Report Series, No. 850. (1995). 97-137
Bricker, D & Squires, J. Ages and Stages Questionnaire. 3rd Ed. Baltimore, MD: Brookes Publishing; 2010.
GlaxoSmithKline. GSK medicine: Bupropion and Paroxetine. Epidemiology study: Preliminary report on bupropion in pregnancy and the occurrence of cardiovascular and major congenital malformation (Study EPIP083). 2006; http://ctr.gsk.co.uk/summary/paroxetime/epip083.pdf.
Demissie, K, Jospeh, KS, Dzakpasu, S. Perinatal Health Indicators for Canada: A Resource Manual. Public Health Agency of Canda, Canadian Perinatal Surveillance System. 2000; Ottawa, ON.
O'Hara MW, Swain AM. Rates and risk of postpartum depression: A meta-analysis. International Review of Psychiatry. 1996;8(1):37-54.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Women's College Hospital
ClinicalTrials.gov Identifier: NCT02116127     History of Changes
Other Study ID Numbers: NI14-020
First Posted: April 16, 2014    Key Record Dates
Last Update Posted: July 31, 2017
Last Verified: July 2017

Keywords provided by Women's College Hospital:
Depression
Pregnancy
Transcranial Direct Current Stimulation

Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders