A Study of the Effects of Lamotrigine or Fluoxetine on the Brain in Bipolar Depression Using an MRI Scan Before and After Treatment
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 13-003660
Sponsor Protocol Number: 13-003660
About this study
This study uses an MRI scan called an MR Spectroscopy to measure brain chemicals before and after treatment with lamotrigine or fluoxetine in patients with bipolar depression. This better understanding of therapy impact on brain function may help individualize future treatment for bipolar depression.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Adolescent and adult subjects, age 18-65.
- Meet all inclusion for 16-week Open Randomized Comparative Effectiveness Trial of Lamotrigine vs. Fluoxetine for Bipolar Depression: Pharmacogenomic and Biomarker Predictors of Response
- Able to complete an MRS brain scan.
Exclusion Criteria:
- Inability or unwilling to provide informed consent.
- Inability to understand English.
- Pregnant subjects will be excluded.
- Subjects who are currently breastfeeding and continue breastfeeding will be excluded.
- Female not practicing a reliable form of birth control (condom, IUD, depo injection)
- History of active substance abuse/dependence within the last 3 months (other than caffeine)
- Unstable active medical illness.
- Mixed hypomania assessed by Young Mania Rating Scale score ≥11
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Mark Frye, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available