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Memantine for the Prevention of Negative Symptomatology

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00148590
First Posted: September 8, 2005
Last Update Posted: October 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
M. Schaefer, MD, Charite University, Berlin, Germany
  Purpose

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: Triple (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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00148590


Locations
Germany
Charité Universitaetsmedizin Berlin; Campus Charité Mitte; Dept. for Psychiatry and Psychotherapy
Berlin, Germany, 10117
Sponsors and Collaborators
M. Schaefer, MD
Stanley Medical Research Institute
Investigators
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
ClinicalTrials.gov Identifier: NCT00148590     History of Changes
Other Study ID Numbers: MIND 1
02T-247 (SMRI)
First Submitted: September 7, 2005
First Posted: September 8, 2005
Last Update Posted: October 18, 2013
Last Verified: October 2013

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

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Memantine
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