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Magnetic Resonance Imaging Study of Lisdexamfetamine for Bipolar Depression

NCT01051440 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2013-01-30

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Shire

    collaborator INDUSTRY

  • Steward St. Elizabeth's Medical Center of Boston, Inc.

    lead OTHER

Principal Investigators

  • Michael E Henry, MD · Steward St. Elizabeth's Medical Center of Boston, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01051440 on ClinicalTrials.gov