Status:
TERMINATED
Memantine for the Treatment of Cognitive Dysfunction and Negative Symptoms in Patients With Chronic Schizophrenia
Lead Sponsor:
M. Schaefer, MD
Collaborating Sponsors:
Stanley Medical Research Institute
Conditions:
Chronic Schizophrenia
Eligibility:
All Genders
18-40 years
Phase:
PHASE3
Brief 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...
Detailed Description
This study examines 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 schizop...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00148616
Start Date
April 1 2004
End Date
December 1 2008
Last Update
June 27 2019
Active Locations (1)
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1
Charité Universitaetsmedizin Berlin; Campus Charité Mitte; Dept. for Psychiatry and Psychotherapy
Berlin, Germany, 10117