Cognitive Enhancement in Bipolar Disorder

NCT ID: NCT00597896

Last Updated: 2015-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2011-04-30

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.

Conditions

Bipolar Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active pramipexole

Day 1: Random assignment to drug or placebo and dosage starting at 0.125 mg BID, which will be increased every week to a target dose of 1.5 mg/day. Targeted maximum dose of 1.5 mg/day is expected to be reached by week 4, however, dosing will be flexible based upon side effects reported. The maximum dose will be 1.5 mg/day.

Group Type: EXPERIMENTAL

pramipexole

Intervention Type: DRUG

po pramipexole versus matching placebo minimum 0.125 mg bid and maximum 0.75 mg bid

Placebo pramipexole

Day 1: Random assignment to drug or placebo and dosage starting at 0.125 mg BID, which will be increased every week to a target dose of 1.5 mg/day. Targeted maximum dose of 1.5 mg/day is expected to be reached by week 4, however, dosing will be flexible based upon side effects reported. The maximum dose will be 1.5 mg/day.

Group Type: PLACEBO_COMPARATOR

pramipexole

Intervention Type: DRUG

po pramipexole versus matching placebo minimum 0.125 mg bid and maximum 0.75 mg bid

Interventions

pramipexole

po pramipexole versus matching placebo minimum 0.125 mg bid and maximum 0.75 mg bid

Intervention Type: DRUG

Other Intervention Names

Mirapex

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanley Medical Research Institute

OTHER

Sponsor Role: collaborator

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Ray, Susan

Senior Research Coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anil K. Malhotra, MD

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Katherine Burdick, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Locations

North Shore - Long Island Jewish Health System

Glen Oaks, New York, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 22152405 (View on PubMed)

Other Identifiers

05T-670

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

05-069

Identifier Type: -

Identifier Source: org_study_id