Not Signed In -
Memantine |
Namenda |
Clinical Trial: Memantine for the Prevention of Negative Symptomatology
This study is currently recruiting patients.
Verified by Charite University, Berlin, Germany September 2005
|
Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
| Schizophrenia | Drug: Memantine | Phase III |
MedlinePlus related topics: Schizophrenia
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Memantine for the Prevention of Negative Symptomatology and Cognitive Impairment in Schizophrenia
Further Study Details:
Primary Outcomes: Changes in PANSS negative subscore between memantine and placebo treatment
Expected Total Enrollment: 40
Expected Total Enrollment: 40
Study start: April 2004
Eligibility
Ages Eligible for Study: 18 Years - 40 Years, Genders Eligible for Study: 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
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00148590
Martin Schaefer, MD +49-30-450-517198 martin.schaefer@charite.de
Germany
Charité Universitaetsmedizin Berlin; Campus Charité Mitte; Dept. for Psychiatry and Psychotherapy, Berlin, 10117, Germany; Recruiting
Michael Krebs, MD +49-30-450-517198 michael.krebs@charite.de
Karolina Leopold, MD +49-30-450-517198 karolina.leopold@charite.de
Michael Krebs, MD, Sub-Investigator
Karolina Leopold, MD, Sub-Investigator
Karolina Leopold, MD +49-30-450-517198 karolina.leopold@charite.de
Michael Krebs, MD, Sub-Investigator
Karolina Leopold, MD, Sub-Investigator
Study chairs or principal investigators
Martin Schaefer, MD, Principal Investigator, Charite Campus Mitte; Dept. of Psychiatry and Psychotherapy
More Information
Study ID Numbers: MIND 1; 02T-247 (SMRI)
Last Updated: September 7, 2005
Record first received: September 7, 2005
ClinicalTrials.gov Identifier: NCT00148590
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 7, 2005
Record first received: September 7, 2005
ClinicalTrials.gov Identifier: NCT00148590
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-09-13
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