Magnetic Resonance Imaging Study of Lisdexamfetamine for Bipolar Depression

December 19, 2012 updated by: Michael Henry, MD, Steward St. Elizabeth's Medical Center of Boston, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
        • Steward St. Elizabeth's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 21 to 50 years.
  • Diagnosed with Bipolar Disorder I or II disorder.
  • Currently in the depressive phase of the illness.
  • Montgomery Asberg Depression Rating Scale (MADRS) score greater than 15.
  • Medication regimen (Lamotrigine, Valproate, Lithium, either alone or in combination with atypical antipsychotics, or typical antipsychotics) at stable doses for at least one month.
  • Has an established residence and phone.
  • Capable of providing informed consent.

Exclusion Criteria:

  • Met Diagnostic and Statistical Manual 4th edition (DSM-IV-TR) criteria for rapid cycling within the 6 months prior to enrolling in the study.
  • Meets DSM-IV-TR criteria for Schizophrenia, Schizoaffective disorder, Post-Traumatic Stress disorder, Obsessive-Compulsive disorder, or Eating disorder. Co-morbid anxiety disorders are not a reason for exclusion.
  • History of psychotic symptoms at any point during the subject's illness.
  • Met DSM-IV-TR criteria for alcohol or substance (except for nicotine) dependence or abuse within the past 6 months.
  • Lifetime history of amphetamine abuse or dependence.
  • Subject has a lifetime history of stimulant-induced mania
  • History of seizures, including febrile seizures in childhood.
  • Young Mania Rating Scale (YMRS) greater than 8.
  • History of significant coronary artery disease, angina, untreated or inadequately treated thyroid disease (less than 1 month chemically euthyroid), type I diabetes, autoimmune disease, glaucoma, hypertension, seizures, or other medical condition(s) which in the opinion of the principal investigator is likely to significantly impact the subject's mood or potential response to the study medication.
  • Electrocardiogram (ECG) with significant arrhythmias or conduction abnormalities, which in the opinion of the physician investigator preclude study participation; uncontrolled hypertension (>160/100) or tachycardia (heart rate >110).
  • Female subjects who are peri or post-menopausal.
  • Subjects taking Ritalin or other stimulants, theophylline, steroids, atomoxetine, cholinesterase inhibitors, memantine, modafinil, warfarin, anticonvulsants, clonidine, theophylline, monoamine oxidase inhibitors, and pseudoephedrine, or other medications that are likely to significantly interact (either pharmacokinetically or pharmacodynamically) with the subject's mood or Lisdexamfetamine.
  • Subject regularly (more than 4 days per week) ingests more than four caffeine containing drinks per day.
  • Pregnancy.
  • In women of childbearing potential, an unwillingness to avoid pregnancy for the duration of the study.
  • Active suicidal ideation.
  • History of homicidal ideation.
  • Allergy or other clinical condition which prohibits the use of all of the approved mood stabilizers or Lisdexamfetamine.
  • Metal in the body (e.g. history of working as a sheet metal worker) or pacemaker which is a contra-indication to magnetic resonance imaging (MRI).
  • Significant claustrophobia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Subjects will receive placebo for lisdexamfetamine.
Drug: Placebo
Subjects will receive placebo matched to lisdexamfetamine.
Active Comparator: Lisdexamfetamine
Subjects will start with 20 mg per day of lisdexamfetamine and may increase to a maximum of 40 mg.
Drug: Lisdexamfetamine
Start at 20 mg daily. Increased to a maximum of 40 mg daily. Can be decreased in 10 mg increments.
Other Names:
  • Vyvanse

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Montgomery Asberg Depression Rating Scale (MADRS) Score Over Time.
Time Frame: baseline and 8 weeks
The change in MADRS score from the baseline visit to the week 8 visit is reported. The MADRS is a clinician-rated scale that consists of 10 items rated on a from 0 to 6 (maximum score of 60), with higher scores indicating greater symptom severity. An increase in score indicates a worsening of symptoms whereas a decrease indicates an improvement in symptoms.
baseline and 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Clinical Global Impressions Severity (CGI-S) Score.
Time Frame: baseline and week 8
The CGI-S score reflects the clinician's overall impression of the patient's functional status. The scoring for the single item ranges from 1 with an anchor of "normal, not at all ill" to 7 with an anchor of "among the most extremely ill patients". Thus, higher scores indicate greater severity of symptoms.
baseline and week 8
Change in Clinical Global Impressions Improvement (CGI-I) Score.
Time Frame: week 1 and week 9
The CGI-I score indicates the clinician's overall assessment of improvement in function from one visit to the next. The single item is scored from 1 to 7 with anchor points ranging from very much improved (1) to very much worse (7). A decrease in score reflects an improvement in functional status.
week 1 and week 9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Shire

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

January 14, 2010

First Submitted That Met QC Criteria

January 15, 2010

First Posted (Estimate)

January 18, 2010

Study Record Updates

Last Update Posted (Estimate)

January 30, 2013

Last Update Submitted That Met QC Criteria

December 19, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00517 (Other Identifier: JJP VAMC IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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