August 2011 By Steward St. Elizabeth's Medical Center of Boston, Inc.
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 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.
||Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
|Ages Eligible for Study:||21 Years|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
- Aged 21 to 50 years.
- Diagnosed with Bipolar Disorder I or II disorder.
- Currently in the depressive phase of the illness.
- MADRS 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
- Has an established residence and phone.
- Capable of providing informed consent.
- Met DSM-IV-TR criteria for rapid cycling within the 6 months prior to enrolling in
- 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.
- 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.
- 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, MAOIs 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.
- 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 MRI scanning.
- Significant claustrophobia.