NCT00741598

The Efficacy and Safety of Galantamine for Dysfunction in Bipolar Disorder

Completed Phase 4 Results posted Last updated 21 March 2017

What this trial tests

Phase 4 trial testing Galantamine-ER in Bipolar Disorder in 72 participants. Completed in 1 May 2014.

Timeline

1 September 2008

Primary endpoint
1 May 2014

1 May 2014

Quick facts

Lead sponsor	Icahn School of Medicine at Mount Sinai
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	72
Start date	1 September 2008
Primary completion	1 May 2014
Estimated completion	1 May 2014
Sites	2 locations across United States

Drugs / interventions tested

• Galantamine-ER
• Galantamine placebo

Conditions studied

• Bipolar Disorder — all drugs for Bipolar Disorder →

Sponsor

Icahn School of Medicine at Mount Sinai

Who can join

Adults 18 to 65, any sex, with Bipolar Disorder. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Scores on the California Verbal Learning Test (CVLT-II) at Screening and Week 16
  Time frame: Measured at screening and Week 16
  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
• Scores on the Wisconsin Card Sorting Test (WCST) at Screening and Week 16
  Time frame: Measured at screening and Week 16
  WCST (Wisconsin Card Sorting Test) is a neuropsychological test measuring the ability to display flexibility in the face of changing schedules of reinforcement. Subjects are presented with cards and requested to match them. Unbeknownst to the subject, the matching rules change while the test is delivered. The test measures subjects' ability to understand the new rules. The outcome measures presen
• The Conners' Continuous Performance Test (CPT) at Baseline, Weeks 4, 8, 12, and 16
  Time frame: Measured at screening; baseline; and Weeks 4, 8, 12, and 16
  Conner's CPT (Conner's Continuous Performance Task) is a neuropsychological test that measures a person's sustained and selective attention. Subjects are instructed to click the space bar when they are presented with any letter except the letter "X". The person must refrain from clicking if they see the letter "X" presented. Clicking to the letter "X" is a commission error, not clicking to other l

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Predictive animal models of mania: hits, misses and future directions.
   Young JW, Henry BL, Geyer MA. · · 2011 · cited 95× · PMID 21410454 · DOI 10.1111/j.1476-5381.2011.01318.x