Official Title: “Memantine for the Prevention of Negative Symptomatology and Cognitive Impairment in Schizophrenia”

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

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: December 2008

Intervention(s) in this Clinical Trial

• Drug: Memantine
  • Daily dose of 10mg memantine Vs. Placebo
• Drug: Placebo
  • Daily dose of 10mg memantine Vs. Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
• Placebo Comparator: Placebo

Primary Measures

• Changes in PANSS negative subscore between memantine and placebo treatment
  • Time Frame: during trial
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 40 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Charite University, Berlin, Germany

Overall Clinical Trial Officials and Contacts

Martin Schaefer, MD Principal Investigator Charite Campus Mitte; Dept. of Psychiatry and Psychotherapy and Department of Psychiatry, Kliniken Essen-Mitte, Essen  

Overall Contact: Martin Schaefer, MD +49-201-174-2200 martin.schaefer@charite.de

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00148590

Study ID Number: MIND 1

ClinicalTrials.gov Identifier: NCT00148590

Health Authority: Germany: Federal Institute for Drugs and Medical Devices