Efficacy Study of Galantamine for Cognitive Impairments in Schizophrenia

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to examine whether adjunctive galantamine is effective in the treatment of cognitive impairments in patients with schizophrenia.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Maryland; University of Maryland, Baltimore
• Collaborators: Ortho-McNeil Neurologics, Inc.; Stanley Medical Research Institute
• Treatments: Galantamine

Criteria

Inclusion Criteria:

1. DSM-IV diagnosis of either schizophrenia or schizoaffective disorder.

2. Males and females

3. Age: 18 and 60

4. Caucasian or Non-Caucasian

5. Subjects will be currently treated with one of the following new generation antipsychotics: olanzapine, risperidone, quetiapine, ziprasidone, or aripiprazole.

6. 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 Criteria:

1. History of an organic brain disease

2. History of DSM-IV alcohol or substance abuse (within the last month), or DSM-IV alcohol or substance dependence (within the last six months).

3. Pregnant women and women taking oral contraceptives (because of the theoretical risk of breakthrough ovulation).

4. Current treatment with galantamine or other acetylcholinesterase inhibitor (e.g. donepezil)

5. History of a second or third degree atrioventricular (AV) block.

6. Persons with chronic medical conditions, which are unstable.