Clinical trial NCT00597896: Cognitive Enhancement in Bipolar Disorder
Official title: Cognitive Enhancement in Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bipolar Disorder
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Stanley Medical Research Institute
First posted: 2008-01-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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 SCID).
* 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 performance.

  * 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. diphenhydramine).
  * 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.

Primary outcomes:
measure: Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Span Subtest (Digits Forward)
timeFrame: Change from Baseline to Week 8
measure: Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Span Subtest (Digits Backward)
timeFrame: Change from Baseline to Week 8
measure: Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Symbol Coding Test
timeFrame: Change from Baseline to Week 8
measure: Change From Baseline to Week 8 in Stroop Color-Word Test
timeFrame: Change from Baseline to Week 8
measure: Change From Baseline to Week 8 in Trail Making Test Part A
timeFrame: Change from Baseline to Week 8
measure: Change From Baseline to Week 8 in Trail Making Test Part B
timeFrame: Change from Baseline to Week 8
measure: Change From Baseline to Week 8 in d2 Test of Attention
timeFrame: Change from Baseline to Week 8
measure: Change From Baseline to Week 8 in Hopkins Verbal Learning Test
timeFrame: Change from Baseline to Week 8
measure: Change From Baseline to Week 8 in Controlled Oral Word Association Test (COWAT) Letter Fluency
timeFrame: Change from Baseline to Week 8
Secondary outcomes:
measure: Double-blind: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint
timeFrame: Change from Baseline to Week 8
measure: Double-blind: Change From Baseline in Clinician-Administered Rating Scale for Mania (CARS-M)Total Score at Endpoint
timeFrame: Change from Baseline to Week 8
Other outcomes:
Locations:
city: Glen Oaks
country: United States
facility: North Shore - Long Island Jewish Health System
state: New York
Study officials:
affiliation: Northwell Health
name: Anil K. Malhotra, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwell Health
name: Katherine Burdick, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Burdick KE, Braga RJ, Nnadi CU, Shaya Y, Stearns WH, Malhotra AK. Placebo-controlled adjunctive trial of pramipexole in patients with bipolar disorder: targeting cognitive dysfunction. J Clin Psychiatry. 2012 Jan;73(1):103-12. doi: 10.4088/JCP.11m07299. Epub 2011 Nov 29.