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Memantine for the Prevention of Negative Symptomatology

This study has been terminated.
Stanley Medical Research Institute
Information provided by (Responsible Party):
M. Schaefer, MD, Charite University, Berlin, Germany Identifier:
First received: September 7, 2005
Last updated: October 17, 2013
Last verified: October 2013

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

Condition Intervention Phase
Schizophrenia Drug: Memantine Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Memantine for the Prevention of Negative Symptomatology and Cognitive Impairment in Schizophrenia

Resource links provided by NLM:

Further study details as provided by M. Schaefer, MD, Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Changes in PANSS negative subscore between memantine and placebo treatment [ Time Frame: during trial ]

Estimated Enrollment: 40
Study Start Date: November 2005
Study Completion Date: December 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: Memantine
Daily dose of 10mg memantine Vs. Placebo
Other Name: Akatinol
Placebo Comparator: Placebo Drug: Placebo
Daily dose of 10mg memantine Vs. Placebo


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00148590

Charité Universitaetsmedizin Berlin; Campus Charité Mitte; Dept. for Psychiatry and Psychotherapy
Berlin, Germany, 10117
Sponsors and Collaborators
M. Schaefer, MD
Stanley Medical Research Institute
Principal Investigator: Martin Schaefer, MD Charite Campus Mitte; Dept. of Psychiatry and Psychotherapy and Department of Psychiatry, Kliniken Essen-Mitte, Essen
  More Information

Responsible Party: M. Schaefer, MD, Professor of Psychiatry, Charite University, Berlin, Germany Identifier: NCT00148590     History of Changes
Other Study ID Numbers: MIND 1
02T-247 (SMRI)
Study First Received: September 7, 2005
Last Updated: October 17, 2013

Keywords provided by M. Schaefer, MD, Charite University, Berlin, Germany:
Negative syndrome
Cognitive impairment

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents processed this record on June 22, 2017