Cognitive Enhancement in Bipolar Disorder - Full Text View

Sponsors and Collaborators:	North Shore Long Island Jewish Health System Stanley Medical Research Institute
Information provided by:	North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:	NCT00597896

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
Official Title:	Cognitive Enhancement in Bipolar Disorder

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Pramipexol Pramipexole dihydrochloride

U.S. FDA Resources

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 ]

Estimated Enrollment:	50
Study Start Date:	October 2005
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active pramipexole: Experimental	Drug: pramipexole po pramipexole versus matching placebo minimum 0.125 mg bid and maximum 0.75 mg bid
Placebo pramipexole: Placebo Comparator	Drug: pramipexole po pramipexole versus matching placebo minimum 0.125 mg bid and maximum 0.75 mg bid

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

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

Contacts

Contact: Yaniv Shaya, MA

718-470-8091

yshaya@nshs.edu

Locations

United States, New York
North Shore - Long Island Jewish Health System	Recruiting
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

Responsible Party:	North Shore Long Island Jewish Health System ( Anil K. Malhotra, MD )
Study ID Numbers:	05-069, 05T-670
Study First Received:	January 8, 2008
Last Updated:	April 22, 2009
ClinicalTrials.gov Identifier:	NCT00597896 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Neurotransmitter Agents
Affective Disorders, Psychotic
Dopamine
Antioxidants
Mental Disorders
Bipolar Disorder

Mood Disorders
Dopamine Agents
Psychotic Disorders
Dopamine Agonists
Pramipexol

Additional relevant MeSH terms:

Neurotransmitter Agents
Disease
Antioxidants
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Bipolar Disorder
Physiological Effects of Drugs
Antiparkinson Agents
Dopamine Agonists
Protective Agents

Pramipexol
Pharmacologic Actions
Affective Disorders, Psychotic
Pathologic Processes
Mental Disorders
Therapeutic Uses
Mood Disorders
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 11, 2009