- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00148590
Memantine for the Prevention of Cognitive Dysfunction and Negative Symptoms in Patients With Acute Schizophrenia
Memantine add-on to Risperidon for Treatment of Negative Symptoms and Cognitive Dysfunction in Patients With Acute Schizophrenia: Results of a Proof of Concept Study
The purpose of this study is to evaluate the efficacy and safety of a 6 weeks memantine add-on to risperidon treatment for the prevention of cognitive dysfunction and negative symptomatology in patients with acute schizophrenia.
Psychopathological changes were assessed with the Positive and Negative Syndrome Scale (PANSS) at baseline and after 2, 4, 6, 12, and 24 weeks. Cognitive function were measured at baseline and week 6, and 24 by the California Verbal Learning Test, Benton Learning Test, Digit Span Forward and Backward Test, Continuous Performance Test, Stroop Test, Trail-Making Test, Verbal Fluency Test, and Wisconsin Card Sorting Test.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Berlin, Germany, 10117
- Charité Universitaetsmedizin Berlin; Campus Charité Mitte; Dept. for Psychiatry and Psychotherapy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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ACTIVE_COMPARATOR: Memantine plus Risperidone
6 weeks 20 mg Memantine as add-on treatment to Risperidone
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Daily dose of 20 mg Memantine add-on to Risperidone vs Placebo add-on to Risperidone
Other Names:
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PLACEBO_COMPARATOR: Placebo plus Risperidone
6 weeks 20 mg Placebo as add-on treatment to Risperidone
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Daily dose of 20 mg Memantine add-on to Risperidone vs Placebo add-on to Risperidone
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in PANSS negative subscore between memantine and placebo treatment
Time Frame: during trial
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during trial
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Neurocognitive Disorders
- Schizophrenia Spectrum and Other Psychotic Disorders
- Cognition Disorders
- Schizophrenia
- Cognitive Dysfunction
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Dopamine Agents
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Memantine
Other Study ID Numbers
- MIND 1
- 02T-247 (SMRI)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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