Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04867889
Status:
WITHDRAWN
Last Update Posted:
2022-11-09
First Post:
2021-04-27
Brief Title:
PREGBRAIN - Magnetic Stimulation of the Brain in Depressed Pregnant Women
Sponsor:
Uppsala University
Organization:
Uppsala University
Study Overview
Official Title:
PREGBRAIN - Magnetic Stimulation of the Brain in Depressed Pregnant Women
Status:
WITHDRAWN
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficult to recruit participants
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 N60 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
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 N60 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None