Status:
COMPLETED
Efficacy Study of Galantamine for Cognitive Impairments in Schizophrenia
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
Stanley Medical Research Institute
Ortho-McNeil Neurologics, Inc.
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to examine whether adjunctive galantamine is effective in the treatment of cognitive impairments in patients with schizophrenia.
Detailed Description
Patients with schizophrenia are characterized by a broad range of neurocognitive abnormalities. These include impairments in attention; eye-tracking; visual and verbal memory; working memory; processi...
Eligibility Criteria
Inclusion
- DSM-IV diagnosis of either schizophrenia or schizoaffective disorder.
- Males and females
- Age: 18 and 60
- Caucasian or Non-Caucasian
- Subjects will be currently treated with one of the following new generation antipsychotics: olanzapine, risperidone, quetiapine, ziprasidone, or aripiprazole.
- Subjects will meet a priori criteria for cognitive impairment severity. The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) will be used to determine the level of cognitive impairment. Patients will meet entry criteria if they have a RBANS total score of 90 or less (one standard deviation below the normal control mean).
Exclusion
- History of an organic brain disease
- History of DSM-IV alcohol or substance abuse (within the last month), or DSM-IV alcohol or substance dependence (within the last six months).
- Pregnant women and women taking oral contraceptives (because of the theoretical risk of breakthrough ovulation).
- Current treatment with galantamine or other acetylcholinesterase inhibitor (e.g. donepezil)
- History of a second or third degree atrioventricular (AV) block.
- Persons with chronic medical conditions, which are unstable.
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT00176423
Start Date
May 1 2002
End Date
December 1 2006
Last Update
December 16 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Maryland Psychiatric Research Center
Baltimore, Maryland, United States, 21228