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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


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


Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Both.


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


- 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

Page last updated: August 23, 2015

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