Cognitive Enhancement in Bipolar Disorder

This study has been completed.
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Ray, Susan, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT00597896
First received: January 8, 2008
Last updated: September 27, 2012
Last verified: September 2012

January 8, 2008
September 27, 2012
October 2005
April 2011   (final data collection date for primary outcome measure)
cognitive functioning [ Time Frame: premedication versus postmedication ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00597896 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Cognitive Enhancement in Bipolar Disorder
Cognitive Enhancement in Bipolar Disorder

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Bipolar Disorder
Drug: pramipexole
po pramipexole versus matching placebo minimum 0.125 mg bid and maximum 0.75 mg bid
Other Name: Mirapex
  • Experimental: Active pramipexole
    Intervention: Drug: pramipexole
  • Placebo Comparator: Placebo pramipexole
    Intervention: Drug: pramipexole
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
April 2011
April 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects between 18 and 65 years of age, who meet 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 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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00597896
05-069, 05T-670
No
Ray, Susan, North Shore Long Island Jewish Health System
North Shore Long Island Jewish Health System
Stanley Medical Research Institute
Principal Investigator: Anil K. Malhotra, MD North Shore Long Island Jewish Health System
Principal Investigator: Katherine Burdick, PhD North Shore Long Island Jewish Health System
North Shore Long Island Jewish Health System
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP