Magnetic Resonance Imaging Study of Lisdexamfetamine for Bipolar Depression
Status:
Terminated
Trial end date:
2011-06-01
Target enrollment:
Participant gender:
Summary
There have been reports that stimulants may be effective for bipolar depression without
triggering mania. This study will examine whether lisdexamfetamine can improve depressive
symptoms over the course of eight weeks. Lisdexamfetamine is a prodrug stimulant that is
currently approved for attention deficit hyperactivity disorder (ADHD). Participants take the
study drug or placebo in addition to a mood stabilizer. The study includes functional
magnetic resonance imaging and magnetic resonance spectroscopy to determine whether the
medication alters the response to affective stimuli or glutamate, glutamine, or gamma
aminobutyric acid (GABA) levels. Neuropsychological testing is also included to determine
whether the study drug improves memory and attention in this population. The primary
hypothesis is that lisdexamfetamine is clinically effective in this population. The secondary
hypothesis is that it will result in an increased response to affective stimuli and altered
neurotransmitter levels in the anterior cingulate cortex.
Phase:
Phase 4
Details
Lead Sponsor:
Steward St. Elizabeth's Medical Center of Boston, Inc.