Vitamin B6 for Mood Changes with Levetiracetam in Brain Tumor Patients
This study is looking at whether taking a Vitamin B6 supplement can help with mood changes, like anger, that some people experience when taking levetiracetam. Levetiracetam is a medication used to prevent seizures in people with brain tumors. If you have a primary brain tumor, are at least 18 years old, and are currently taking levetiracetam, you might be able to join. The study will give you 100 mg of Vitamin B6 to take daily for 8 to 12 weeks, in addition to your regular levetiracetam. Researchers will ask you and a caregiver to fill out questionnaires to see if your mood improves. The study is currently unclear on its recruitment status and plans to enroll 50 participants.
- Study design
- This is an interventional study, meaning participants will receive an intervention (Vitamin B6). It plans to enroll 50 participants.
- What's involved
- You would take a 100 mg Vitamin B6 supplement daily for 8 to 12 weeks. You and a caregiver will also complete questionnaires to assess your mood at the start and after 8-12 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your mood will be assessed at the start of the study and again 8 to 12 weeks after you begin taking Vitamin B6.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
B6 Administration for Levetiracetam-Associated Neurobehavioral Changes and Epilepsy
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Katherine Peters, MD, PhD · PRINCIPAL_INVESTIGATOR · Duke University
Who to contact
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What this trial measures
- Efficacy of VitB6 supplementation on LEV-associated mood changes in patients with BTRE, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) anger questionnaireFrom enrollment (Baseline) to follow-up at 8-12 weeks from the initiation of VitB6 supplementation
Mean change in patient-reported PROMIS anger T-scores between baseline and the 8 to 12-week follow-up visit among patients who complete questionnaires at both timepoints. Each item on the PROMIS Anger Short Form is rated on a 5-point scale. The total score can range from 5 to 25, with higher scores indicating greater severity of anger.