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Efficacy and Safety of Galantamine for Improving Dysfunction in People With Bipolar Disorder

NCT00741598 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2017-05-02

Study results available
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Summary

This study will examine whether extended release galantamine, a drug approved by the Food and Drug Administration to reduce cognitive impairments in people with Alzheimer's disease, can perform the same function in stable people with bipolar disorder.

Conditions

Interventions

DRUG

Galantamine-ER

Galantamine-ER 8 to 24 mg per day for 16 weeks

DRUG

Galantamine placebo

Galantamine placebo 8 to 24 mg per day for 16 weeks

Sponsors & Collaborators

Principal Investigators

  • Dan V. Iosifescu, MD · Icahn School of Medicine at Mount Sinai & Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00741598 on ClinicalTrials.gov