The purpose of this study is to examine whether the medication pramipexole (Mirapex) may be
able to improve cognitive problems (i.e. difficulties with thinking, memory, and
concentration) that may be associated with bipolar disorder.
To address the primary aim, the study is an eight-week, randomized, double-blind,
placebo-controlled treatment trial of pramipexole in 50 euthymic bipolar I and II disorder
(BPD) patients, who demonstrate cognitive impairment.
- Subjects between 18 and 65 years of age, who meet Diagnostic and Statistical Manual
of Mental Disorders, 4th edition (DSM-IV) criteria for BPD I or II (by SCID) and
confirmed in the diagnostic consensus conference will be included.
- Subjects must also meet criteria for euthymia described above.
- All subjects must be taking a standard mood stabilizer at a stable therapeutic dose
(i.e. lithium, carbamazepine, valproate, lamotrigine).
- Subjects with a history of central nervous system (CNS) trauma, neurological
disorder, Attention Deficit Hyperactivity Disorder (ADHD), or learning disability
will be excluded.
- Subjects with a DSM-IV diagnosis of current or recent substance abuse or dependence
(in the previous 1 month) will be excluded.
- Moreover, subjects with rapid-cycling during the past year will be excluded (based on
- Any subject with an active, unstable medical problem that may interfere with
cognition will be excluded based on the investigator's judgment.
- While medication status is an important consideration in any study of bipolar
disorder, the exclusion of patients taking any medication is not practical, given the
high prevalence of combination pharmacotherapy for bipolar disorder. To help control
for medication effects on cognition, we plan to limit the types of medications
allowed by excluding certain medications with a known impact on cognitive
- Subjects taking clozapine will be excluded due to it's potential overlapping
mechanisms of action with pramipexole.
- Subjects taking prescription or over-the counter medications may also be
excluded if these medications have been shown to impact cognition (i.e.
- The use of benzodiazepines, sedatives, or sleeping pills, within 6 hours of
neurocognitive testing will not be allowed. In addition, patients taking
topiramate, tricyclic antidepressants, or anticholinergic medications that are
known to impact cognition will be excluded from participation.
- Subjects taking any medications that are known to interact with pramipexole
(i.e. Zantac, Tagamet, Reglan, Benemid, Probalan, Compazine, Phenergan,
quinidine, selegiline, verapamil, and any other medication with a known
interaction) will also be excluded.