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Completed

NCT Number: NCT00195845

A Double-Blind, Placebo-Controlled Study of Galantamine to Improve Cognitive Dysfunction in Bipolar Disorder

The purpose of this study is to determine if galantamine augmentaion improves cognition in euthymic bipolar patients. In addition, the effect of galantamine on clinical measures of functioning and psychopathology will also be assessed.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cambridge Health Alliance

Cambridge, Massachusetts, 02139, United States

About this study

The study length is 12 to 24 weeks depending on whether patients enter the crossover. Study also involves 3 neuropsychology testings.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-60; DSM-IV diagnosis of bipolar disorder, any subtype; Baseline Mini Mental Status exam above 20; MRS < 16; MADRS < 16

Exclusion criteria

  • Current substance dependence; serious unstable medical conditions; active suicidal ideation; current DSM-IV for a major mood episodes; history of COPD, epilepsy, cardiac arrhythmia, and peptic ulcer disease; meet DSM-IV criteria for dementia

Treatment and study plan

Galantamine

Drug

Placebos

Drug

Primary outcomes

  1. Cognitive Function

    Time frame: 6 Months

Sponsors and collaborators

Lead sponsor

Cambridge Health Alliance

Other

Collaborators

  • Northwestern University

Registry information

Official study title

A Phase 4 Double-Blind, Placebo-Controlled Study of Galantamine to Improve Cognitive Dysfunction in Bipolar Disorder

Important dates

Study start
2003
Primary completion
2006
Study completion
2007
First posted
Sep 20, 2005
Registry last updated
Apr 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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