drugset / Trial / NCT01051440

Magnetic Resonance Imaging Study of Lisdexamfetamine for Bipolar Depression

NCT01051440

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2010-02
Primary completion
2011-06
Completion
2011-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Lisdexamfetamine Other / unclassified 40 mg

Indications