Systematic review and meta-analysis to examine the risk of psychiatric AEs associated with topiramate use. Investigators are requesting access to CSRs of 38 RCTs via the YODA Project, not IPD. From the CSR AE summaries, they will ascertain psychiatric AE counts for their meta-analysis. Results of this work will be informative to patients and clinicians alike. I would only recommend that they register their review protocol in PROSPERO, so others can know they are working on this question and provide feedback as appropriate.
Recommendation for this data request: Approve