Memantine for the Prevention of Negative Symptomatology
Information source: Charite University, Berlin, Germany
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: Memantine (Drug); Placebo (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: M. Schaefer, MD Official(s) and/or principal investigator(s):
Martin Schaefer, MD, Principal Investigator, Affiliation: Charite Campus Mitte; Dept. of Psychiatry and Psychotherapy and Department of Psychiatry, Kliniken Essen-Mitte, Essen
Summary
The purpose of this study is to evaluate the efficacy and safety of memantine as add-on
treatment for the prevention of negative symptomatology in patients with an acute
exacerbation of schizophrenia.
Primary outcome parameter are negative symptoms after 6 months
Clinical Details
Official title: Memantine for the Prevention of Negative Symptomatology and Cognitive Impairment in Schizophrenia
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Primary outcome: Changes in PANSS negative subscore between memantine and placebo treatment
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Both.
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
Locations and Contacts
Charité Universitaetsmedizin Berlin; Campus Charité Mitte; Dept. for Psychiatry and Psychotherapy, Berlin 10117, Germany
Additional Information
Starting date: November 2005
Last updated: October 17, 2013
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