Status:
TERMINATED
Memantine for the Prevention of Cognitive Dysfunction and Negative Symptoms in Patients With Acute Schizophrenia
Lead Sponsor:
M. Schaefer, MD
Collaborating Sponsors:
Stanley Medical Research Institute
Conditions:
Schizophrenia
Eligibility:
All Genders
18-40 years
Phase:
PHASE3
Brief 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 patien...
Detailed Description
This study examines 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 schizop...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00148590
Start Date
November 1 2005
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