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Developing a non-drug treatment for depression during pregnancy – research at King’s College London

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spjumic Mon 29-Feb-16 10:51:12

DEVELOPING A NON-DRUG TREATMENT FOR DEPRESSION DURING PREGNANCY – RESEARCH AT KING’S COLLEGE LONDON

BACKGROUND:
Approximately 10% of pregnant women suffer from depression. However, due to concerns about the risks of medication many pregnant women refuse anti-depressant treatment, and it is reported that 60% of women taking antidepressants will stop them when they discover they are pregnant.
Repetitive Transcranial Magnetic Stimulation (rTMS) is a ‘brain stimulation’ technique that does not involve anything being inserted into the woman’s body. It has the potential to provide an effective and safe means of treating depression in pregnant women who decline pharmacological treatment.
RTMS delivers short magnetic pulses over the scalp with the aim of stimulating underlying brain regions that are involved in mood (particularly a region at the front of the brain called the dorsolateral prefrontal cortex (DLPFC)). The magnetic pulses cause changes in the brain that last for some time after you have been treated and can improve your mood.

(Please see picture of rTMS machine attached)

There have been a significant number studies into the positive effects of rTMS on depression. It is widely used as a licensed treatment for depression in the USA and across Europe, and the National Institute for Health and Care Excellence (NICE) have commented on the ‘consistently positive outcomes in [rTMS] for depression in many studies’ (December 2015).
There have only been a few studies of the benefits of rTMS in the UK. Although the research done so far has reported that rTMS is tolerated by patients and appears to quicken recovery from depression, we need to find out more about how well it works in pregnancy.
In the proposed study depressed pregnant women, who do not wish to take medication in pregnancy, will be invited to take part. The women who choose to take part will have an equal chance of receiving either the ‘real’ or a ‘sham’ (pretend) rTMS. Both types of treatment will involve attendance at 20 sessions, which take place over a period of 4 weeks. Neither the women who take part nor the researchers will know who is receiving the ‘real’ treatment or who is receiving the ‘sham’ treatment.

After the treatment sessions have finished and the effect of the treatment on the participating woman has been assessed, both researchers and the woman concerned will find out whether she has received either the ‘real’ or ‘sham’ treatment. If a woman finds out she was given the ‘sham’ treatment and is still depressed, she will be offered the ‘real’ treatment. It will be her decision whether or not to take this offer up. All other women will continue to receive their antenatal care as usual.

Safety of your Unborn Child: The unborn child isn’t exposed to magnetic fields during rTMS treatment. Previous research into rTMS hasn’t found any harm to be suffered by the unborn child.

Safety of the Mother: The main risk with rTMS is the risk of having a seizure. However, this risk is extremely low (<0.1%) and less than that associated with taking antidepressant medication.

Before starting this proposed study it is important for us get feedback from people who might consider / have considered rTMS treatment if it were offered to them. We would therefore be grateful if you would answer the following questions:

QUESTIONS:
1.If you were/are depressed in pregnancy would you consider the type of treatment being suggested?

2.Would you consider taking part in a trial where there is a 50% chance of getting sham (pretend) treatment for 4 weeks?

3.If you got ‘sham’ / pretend treatment for 4 weeks, and were then offered real treatment (if you were still depressed) would you agree to take part?

4.The study will involve coming to Kings College Hospital 5 days per week for 4 weeks. Is this something you could do?

5.If we arranged and paid for your transport would that make a big difference to you agreeing to take part?

6.What would be your main concerns about taking part in this study?

Thank you for your help,

Michael Craig PhD FRCOG FRCPsych
michael.c.craig@kcl.ac.uk
Mobile: 0 78 1213 2524

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