Memantine for the Treatment of Cognitive Dysfunction and Negative Symptoms in Patients With Chronic 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 24 weeks memantine add-on treatment to risperidone for the treatment of negative symptomatology and cognitive impairment in patients with chronic schizophrenia.

• 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

• Stable negative syndrome (PANSS negative score > 20)

• At least one previous schizophrenic episode

• Informed consent

• Subjects must be considered by the investigator to be compliant with investigations and appointments

• 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 positive symptomatology (PANNS positive score > PANNS negative score)

• 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