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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02116127
• Other study ID #: NI14-020
• Status: Completed
• Phase: N/A
• First received: April 2, 2014
• Last updated: July 27, 2017
• Start date: April 2014
• Est. completion date: July 2017

Study information

• Verified date: July 2017
• Source: Women's College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Pregnancy

Intervention

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 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.

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	Women's College Hospital	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Women's College Hospital	Centre for Addiction and Mental Health, Mount Sinai Hospital, Canada

Country where clinical trial is conducted

Canada, 

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* Note: There are 109 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants recruited over 1 year	Feasibility	Up to one year from when the study starts enrolling participants
Secondary	Montgomery Asberg Depression Rating Scale	Efficacy - Depression Symptom Measurement	End of week 1
Secondary	Edinburgh Postnatal Depression Scale	Efficacy - Depression Symptom Measurement	End of Week 1
Secondary	Pregnancy Experience Scale	Efficacy - Secondary Symptom Measurement	End of Week 1
Secondary	State-Trait Anxiety Inventory	Efficacy - Secondary Symptom Measurement	End of week 1
Secondary	Itemized neonatal health outcomes questionnaire	Neonatal outcome (safety)	4 weeks postpartum
Secondary	Itemized neonatal health outcomes questionnaire	Neonatal Outcome (safety)	12 weeks postpartum
Secondary	Bates Infant Characteristics Questionnaire	Infant outcome (temperament)	12 weeks postpartum
Secondary	Ages and Stages Questionnaire	Infant outcome (development)	12 weeks postpartum
Secondary	Toronto Side Effects Scale	Acceptability - side effects	End of Week 1
Secondary	Toronto Side Effects Scale	Acceptability - side effects	End of week 2
Secondary	Toronto Side Effects Scale	Acceptability - side effects	End of intervention phase (end of week 3)
Secondary	Itemized treatment acceptability questionnaire	Acceptability - barriers and facilitators of attending appointments	End of intervention phase (end of week 3)
Secondary	Pregnancy Complications Itemized Questionnaire		End of week 1
Secondary	Pregnancy Complications Itemized Questionnaire		End of week 2
Secondary	Pregnancy Complications Itemized Questionnaire		End of intervention phase (end of week 3)
Secondary	Pregnancy Complications Itemized Questionnaire		Every 4 weeks until delivery of baby (up to 26 weeks from initial randomization)
Secondary	Pregnancy Complications Itemized Questionnaire		4 weeks postpartum
Secondary	Rate of follow-up data collection		12 weeks postpartum
Secondary	Completion of all 15 treatment sessions		End of intervention phase (end of week 3)
Secondary	Treatment allocation questionnaire		End of week 1
Secondary	Treatment allocation questionnaire		End of intervention phase (end of week 3)
Secondary	Montgomery Asberg Depression Rating Scale	Efficacy - Depression Symptom Measurement	End of week 2
Secondary	Edinburgh Postnatal Depression Scale	Efficacy - Depression Symptom Measurement	End of Week 2
Secondary	Montgomery Asberg Depression Rating Scale	Efficacy - Depression Symptom Measurement	End of intervention phase (End of week 3)
Secondary	Montgomery Asberg Depression Rating Scale	Efficacy - Depression Symptom Measurement	Every 4 weeks until delivery (i.e. up to 26 weeks from initial randomization)
Secondary	Montgomery Asberg Depression Rating Scale	Efficacy - Depression Symptom Measurement	4 weeks postpartum
Secondary	Montgomery Asberg Depression Rating Scale	Efficacy - Depression Symptom Measurement	12 weeks postpartum
Secondary	Edinburgh Postnatal Depression Scale	Efficacy - Depression Symptom Measurement	End of intervention phase (Week 3)
Secondary	Edinburgh Postnatal Depression Scale	Efficacy - Depression Symptom Measurement	Every 4 weeks until delivery (i.e. up to 26 weeks from initial randomization)
Secondary	Edinburgh Postnatal Depression Scale	Efficacy - Depression Symptom Measurement	4 weeks postpartum
Secondary	Edinburgh Postnatal Depression Scale	Efficacy - Depression Symptom Measurement	12 weeks postpartum
Secondary	Pregnancy Experience Scale	Efficacy - Secondary Symptom Measurement	End of Week 2
Secondary	Pregnancy Experience Scale	Efficacy - Secondary Symptom Measurement	End of intervention phase (Week 3)
Secondary	Pregnancy Experience Scale	Efficacy - Secondary Symptom Measurement	Every 4 weeks until delivery (i.e. up to 26 weeks from initial randomization)
Secondary	State-Trait Anxiety Inventory	Efficacy - Secondary Symptom Measurement	End of week 2
Secondary	State-Trait Anxiety Inventory	Efficacy - Secondary Symptom Measurement	End of intervention phase (end of week 3)
Secondary	State-Trait Anxiety Inventory	Efficacy - Secondary Symptom Measurement	Every 4 weeks until delivery (i.e. up to 26 weeks from initial randomization)
Secondary	State-Trait Anxiety Inventory	Efficacy - Secondary Symptom Measurement	4 weeks postpartum
Secondary	State-Trait Anxiety Inventory	Efficacy - Secondary Symptom Measurement	12 weeks postpartum