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
  Purpose

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.


Condition Intervention Phase
Bipolar Disorder
Drug: pramipexole
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Enhancement in Bipolar Disorder

Resource links provided by NLM:


Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • cognitive functioning [ Time Frame: premedication versus postmedication ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: October 2005
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active pramipexole Drug: pramipexole
po pramipexole versus matching placebo minimum 0.125 mg bid and maximum 0.75 mg bid
Other Name: Mirapex
Placebo Comparator: Placebo pramipexole Drug: pramipexole
po pramipexole versus matching placebo minimum 0.125 mg bid and maximum 0.75 mg bid
Other Name: Mirapex

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00597896

Locations
United States, New York
North Shore - Long Island Jewish Health System
Glen Oaks, New York, United States, 11004
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Stanley Medical Research Institute
Investigators
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
  More Information

No publications provided by North Shore Long Island Jewish Health System

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ray, Susan, Senior Research Coordinator, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT00597896     History of Changes
Other Study ID Numbers: 05-069, 05T-670
Study First Received: January 8, 2008
Last Updated: September 27, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Pramipexole
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on August 19, 2014