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Memantine |
Namenda |
Clinical Trial: Memantine for the Treatment 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 treatment of negative symptomatology and cognitive impairment in patients with chronic schizophrenia.
Primary outcome parameter are changes in negative symptoms between baseline and 6 months
| Condition | Intervention | Phase |
|---|---|---|
| Chronic schizophrenia | Drug: Memantine | Phase III |
MedlinePlus related topics: Schizophrenia
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
Official Title: Memantine for the Treatment 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
- Stable negative syndrome (PANSS negative score > 20)
- At least one previous schizophrenic episode
- Informed consent
- Subjects must be considered by the investigator to be compliant with investigations and appointments
- 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 positive symptomatology (PANNS positive score > PANNS negative score)
- 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
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00148616
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 +49-30-450-517199 karolina.leopold@charite.de
Michael Krebs, MD, Sub-Investigator
Karolina Leopold, MD, Sub-Investigator
Karolina Leopold, MD +49-30-450-517199 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 2; 02T-247 (SMRI)
Last Updated: September 7, 2005
Record first received: September 7, 2005
ClinicalTrials.gov Identifier: NCT00148616
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: NCT00148616
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-09-13
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