PREGBRAIN - Magnetic Stimulation of the Brain in Depressed Pregnant Women

  • STATUS
    Recruiting
  • End date
    Jun 3, 2024
  • participants needed
    60
  • sponsor
    Uppsala University
Updated on 6 October 2021
depressive symptoms
depressed mood
depressive episode
transcranial magnetic stimulation

Summary

Background

Depression during pregnancy is common, afflicting 10-20% of pregnant women. Nevertheless, many women want to avoid antidepressant treatment during pregnancy, due to the possible impact on the unborn child.

rTMS (repetitive transcranial magnetic stimulation) is a method where an electromagnetic coil is placed close to the head. Magnetic pulses will induce an electrical current in specific nerve cells, depending on how the coil is placed. Thousands of patients have been treated with rTMS to date, and the effect on depressive symptoms is well documented, although the exact mechanism of the effect is not yet fully understood. Of late, an alternative treatment regime called intermittent theta burst stimulation (iTBS) has been developed. The treatment time per session for iTBS is much shorter than standard rTMS, which will render the treatment much more clinically acceptable. rTMS in pregnancy has not been extensively studied, but seems to have good effect and few side effects.

Method

Pregnant women (N=60) with depressive symptoms will be assessed by a psychiatrist, and women fulfilling the criteria for a moderate-severe depressive episode can be included. Participants will be randomized to either active or sham treatment. Treatment will be administered during 20 days, once daily (4 minutes per session). A psychiatrist will assess depressive symptoms before, as well as 2 and 4 weeks after, treatment start. Women randomized to the sham treatment will, after the initial blind phase, be offered active treatment, following the same protocol as above. Women who have responded to the treatment, but are not in remission after the first four weeks will be offered an additional two weeks of iTBS treatment, in accordance with clinical protocol.

Three, 6 and 12 months after the treatment is completed, all participants will be followed up via a web-based questionnaire.

Apart from assessment of mood symptoms, treatment effects is also assessed using structural and functional magnetic resonance imaging (MRI). MRI will be performed once before treatment start, and once before at the very end of the blind phase of the study (four weeks).

A random selection of the participating women will be invited to a sub-study and interviewed once during pregnancy as well as a second time 4-6 months postpartum. Questions will include inter alia their own description of being pregnant and depressed.

Details
Condition Endogenous depression, Depression (Pediatric), Depression, Depression (Major/Severe), depressive disorder, Depression (Adult and Geriatric), Depressed, Pregnancy Related, Depression (Treatment-Resistant), miserable, depressed mood, Depression (Adolescent), depressive disorders
Treatment Sham iTBS, iTBS (intermittent theta-burst stimulation)
Clinical Study IdentifierNCT04867889
SponsorUppsala University
Last Modified on6 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Pregnant women over the age of 18 with a diagnosis of uni- or bipolar depression verified through a Mini International Neuropsychiatric Interview (M.I.N.I.) (44), and with unchanged medication the past month
Provision of signed informed consent form

Exclusion Criteria

Epilepsy, conductive ferromagnetic or other magnetic sensitive metals implanted in the head or within 30 cm of the treatment coil (examples cochlear implants, implanted electrodes/stimulators, aneurysm clips or coils, stents and bullet fragments), implanted device that is activated or controlled in any way by physiological signals such as pacemakers, implantable cardioverter-defibrillators (ICD's), vagus nerve stimulators, wearable cardioverter-defibrillators, implanted mediation pumps, intracardiac lines, even when removed, addiction (illicit drugs or alcohol), pre-eclampsia/eclampsia, previous preterm birth and/or treatment with any medication that could lower the threshold for seizures
Any condition that seriously increases the risk of non-compliance or loss of follow-up
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