A Study of the Effects of Lamotrigine or Fluoxetine on the Brain in Bipolar Depression Using an MRI Scan Before and After Treatment

Overview

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

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

.
CLS-20151560

Mayo Clinic Footer