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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00195845

Enrollment

Registered

2005-09-20

Start date

2003-04-30

Completion date

2007-02-28

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder

Brief summary

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.

Detailed description

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

Interventions

DRUGGalantamine

DRUGPlacebos

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Cognitive Function	6 Months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026