NCT01051440

Magnetic Resonance Imaging Study of Lisdexamfetamine for Bipolar Depression

A Magnetic Resonance Spectroscopy and fMRI Study of the Effects of Lisdexamfetamine on Bipolar Depression

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Steward St. Elizabeth's Medical Center of Boston, Inc. · Academic / Other
• Sex: All
• Age: 21 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bipolar Depression

Interventions

Type	Name	Description
DRUG	Lisdexamfetamine	Start at 20 mg daily. Increased to a maximum of 40 mg daily. Can be decreased in 10 mg increments.
DRUG	Placebo	Subjects will receive placebo matched to lisdexamfetamine.

Timeline

• Start date: 2010-02-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2010-01-18
• Last updated: 2013-01-30
• Results posted: 2013-01-30

Locations

1 site across 1 country: United States