Memantine for the Prevention of Cognitive Dysfunction and Negative Symptoms in Patients With Acute Schizophrenia

• Status: Terminated
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of a 6 weeks memantine add-on to risperidon treatment for the prevention of cognitive dysfunction and negative symptomatology in patients with acute schizophrenia.

Psychopathological changes were assessed with the Positive and Negative Syndrome Scale (PANSS) at baseline and after 2, 4, 6, 12, and 24 weeks. Cognitive function were measured at baseline and week 6, and 24 by the California Verbal Learning Test, Benton Learning Test, Digit Span Forward and Backward Test, Continuous Performance Test, Stroop Test, Trail-Making Test, Verbal Fluency Test, and Wisconsin Card Sorting Test.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M. Schaefer, MD
• Collaborator: Stanley Medical Research Institute
• Treatments: Memantine

Criteria

Inclusion Criteria:

• Diagnosis of schizophrenia (DSM-IV)

• Age 18 to 40

• Exacerbation of an acute schizophrenic episode (PANSS positive score > 20)

• At least one previous schizophrenic episode

• Informed consent

• Subjects must be considered by the investigator to be compliant

• Subjects must have an educational level and a degree of understanding such that they can meaningfully communicate with the investigator

Exclusion Criteria:

• Axis I disorder other than schizophrenia within 12 months, e.g. schizoaffective disorder

• Severe negative symptomatology (PANNS negative score >20 points)

• Duration of schizophrenia > 5 years

• Dependency on alcohol or addictive drugs within 6 months of the baseline evaluation

• Contraindication of risperidone

• Significant neurological, cardiovascular, hepatic, renal, metabolic, or other medical diseases or any clinically relevant abnormalities in laboratory tests

• Prior ECT-treatment, metal implantations

• Female subjects during pregnancy and breastfeeding

• Female subjects within childbearing years who were not using adequate birth control

• Patients who are judged by the investigator to be at serious suicide risk