PREGBRAIN - Magnetic Stimulation of the Brain in Depressed Pregnant Women
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Depression
- Pregnancy Related
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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.Masking: Triple (Participant, Care Provider, Investigator)Masking Description: Randomization into the study will be conducted by stratified block randomization. Randomization will be created via the RedCap system and a special assigned randomization personnel (the randomizer) not otherwise involved in the study. The randomizer has access to a set of patient identification codes to the Magpro X100 that determines if the patient will be given active or sham treatment. When a patient has been recruited to the study the rTMS operator will open next randomization envelope to achieve a patient code for the machine and will thereby be blinded to treatment allocation of the patientPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 50 years
- Gender
- Only males
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT04867889
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Robert Bodén, MD, ass prof Uppsala University
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