Clinical trial NCT04867889: PREGBRAIN - Magnetic Stimulation of the Brain in Depressed Pregnant Women
Official title: PREGBRAIN - Magnetic Stimulation of the Brain in Depressed Pregnant Women
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Depression
Pregnancy Related
Keywords: depression
pregnancy
transcranial magnetic stimulation
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2021-04-30
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a four week parallel randomized controlled trial, with two arms; the first following a protocol for magnetic stimulation of the brain with intermittent theta-burst stimulation (iTBS), with one session daily for four weeks, and the other the same protocol with a sham coil (both treatment arms will have 20 sessions in total). Apart from assessment of mood symptoms, treatment effects is also assessed using structural and functional magnetic resonance imaging.

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.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. Provision of signed informed consent form

Exclusion Criteria:

1. 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.
2. Any condition that seriously increases the risk of non-compliance or loss of follow-up

Primary outcomes:
measure: Difference in MADRS-rating from baseline to day of the last treatment in the blind phase
timeFrame: 4 weeks
Secondary outcomes:
measure: Difference in MADRS-rating from baseline to two weeks after first iTBS treatment
timeFrame: 4 weeks
measure: Duration of treatment effects of iTBS on symptoms in depression
timeFrame: 1 year
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Brain Stimulation Unit, Uppsala university hospital
state: Region Uppsala
Study officials:
affiliation: Uppsala University
name: Robert Bodén, MD, ass prof
role: PRINCIPAL_INVESTIGATOR
References: