NCT04867889

PREGBRAIN - Magnetic Stimulation of the Brain in Depressed Pregnant Women

Withdrawn NA Last updated 19 July 2024

What this trial tests

NA trial testing iTBS (intermittent theta-burst stimulation) in Depression. Withdrawn.

Timeline

31 December 2022

Primary endpoint
31 December 2023

9 February 2024

Quick facts

Lead sponsor	Uppsala University
Phase	NA
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Start date	31 December 2022
Primary completion	31 December 2023
Estimated completion	9 February 2024
Sites	1 location across Sweden

Drugs / interventions tested

• iTBS (intermittent theta-burst stimulation)
• Sham iTBS

Conditions studied

• Depression — all drugs for Depression →
• Pregnancy Related — all drugs for Pregnancy Related →

Sponsor

Uppsala University

Who can join

Adults 18 to 50, female only, with Depression or Pregnancy Related. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.