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NCT00741598 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study, sponsored by Icahn School of Medicine at Mount Sinai.

Completed
Registry status
Phase 4
Development phase
72
Enrollment target

NCT00741598: Completed Phase 4 study, sponsored by Icahn School of Medicine at Mount Sinai.

NCT00741598 is a Phase 4 study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 72 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00741598, a Phase 4 study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.

COMPLETED
Registry status
Phase 4
Development phase
72 participants
Enrollment target

Study 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.

Primary Outcome

CVLT is a test measuring verbal learning and verbal memory. Subjects are expected to remember a list of words. They are asked to repeat the words remembered 5 times (5 trials). Each of the words correctly remembered, in each trial, is marked as 1 point. The outcome measures presented are: CVLT Total Trials 1-5, Baseline = Number of total words remembered, sum of trials 1-5, at baseline CVLT Total Trials 1-5, Week 16 = Number of total words remembered, sum of trials 1-5, at week 16.

Interventions

  • DRUG Galantamine-ER
  • DRUG Galantamine placebo

Trial Details

FieldValue
Enrollment Target 72 participants
Start Date 2008-09
Est. Completion 2014-05
Phase Phase 4

What the finished NCT00741598 record still lists

NCT00741598 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower).

The record links to 0 conditions, and to 2 interventions - of which Galantamine-ER is the first listed.

NCT00741598 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00741598 about?

NCT00741598 is a clinical study titled "Efficacy and Safety of Galantamine for Improving Dysfunction in People With Bipolar Disorder". 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.

What is the current status of trial NCT00741598?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 72 participants. The study started on 2008-09. Estimated completion is 2014-05.

What interventions are being tested in trial NCT00741598?

The interventions under investigation include: Galantamine-ER (DRUG), Galantamine placebo (DRUG).

Who is sponsoring clinical trial NCT00741598?

This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00741598's enrollment target sits among peer trials

72 1035th of 2000 higher than 961 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00741598, the US trial registry maintained by the National Library of Medicine. NCT00741598 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.