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

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Trial Conditions
  • Bipolar Depression
What is the purpose of this trial?

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.

Date & Status


Who can Participate?


21  - 50 



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.

Gender: Both
Steward Physician(s)
  • Michael E Henry, MD
  • St. Elizabeth's Medical Center - Terminated
Trial Interventions
  • Lisdexamfetamine
  • Placebo
Physician Researcher

Investigator Name:

  • Michael E Henry, MD

Other Information

Sponsor: Steward St. Elizabeth's Medical Center of Boston, Inc.
Phase: Phase 4
Trial ID: NCT01051440
Volunteers:  Not Accepting Healthy Volunteers

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