Magnetic Resonance Imaging Study of Lisdexamfetamine for Bipolar Depression

NCT ID: NCT01051440

Last Updated: 2013-01-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2011-06-30

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.

Conditions

Bipolar Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Subjects will receive placebo for lisdexamfetamine.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Subjects will receive placebo matched to lisdexamfetamine.

Lisdexamfetamine

Subjects will start with 20 mg per day of lisdexamfetamine and may increase to a maximum of 40 mg.

Group Type: ACTIVE_COMPARATOR

Lisdexamfetamine

Intervention Type: DRUG

Start at 20 mg daily. Increased to a maximum of 40 mg daily. Can be decreased in 10 mg increments.

Interventions

Lisdexamfetamine

Start at 20 mg daily. Increased to a maximum of 40 mg daily. Can be decreased in 10 mg increments.

Intervention Type: DRUG

Placebo

Subjects will receive placebo matched to lisdexamfetamine.

Intervention Type: DRUG

Other Intervention Names

Vyvanse

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shire

INDUSTRY

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Michael Henry, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael E Henry, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Steward St. Elizabeth's Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

00517

Identifier Type: -

Identifier Source: org_study_id