Conditions: Bipolar Depression
Keywords: lisdexamfetamine vyvanse bipolar disorder depression stimulant magnetic resonance spectroscopy functional magnetic resonance imaging neuropsychological testing
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Subjects will receive placebo for lisdexamfetamine. arm 2: Subjects will start with 20 mg per day of lisdexamfetamine and may increase to a maximum of 40 mg.

Interventions: intervention 1: Lisdexamfetamine intervention 2: Placebo
Intervention descriptions: intervention 1: Start at 20 mg daily. Increased to a maximum of 40 mg daily. Can be decreased in 10 mg increments. intervention 2: Subjects will receive placebo matched to lisdexamfetamine.

Protocol document: