CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 72 enrolled
Drug / intervention
Galantamine-ER +1 moredrug
Likely dose
Galantamine-ER 24 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00741598
NCT00741598Phase 4Completed
CompareCT.gov

The Efficacy and Safety of Galantamine for Dysfunction in Bipolar Disorder

Icahn School of Medicine at Mount Sinai·interventional·Posted Aug 26, 2008·Updated May 2, 2017

In Brief

A Phase 4 clinical trial evaluating Galantamine-ER and Galantamine placebo for Bipolar Disorder. Completed, enrolled 72 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH), Massachusetts General Hospital

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 26, 2008
Enrollment StartSep 1, 2008
Primary CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 17.8 years ago

Interventions

Galantamine-ERdrug

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

Galantamine placebodrug

Galantamine placebo 8 to 24 mg per day for 16 weeks