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Memantine for the Prevention of Negative Symptomatology

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
M. Schaefer, MD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00148590
First received: September 7, 2005
Last updated: February 10, 2012
Last verified: February 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Memantine for the Prevention of Negative Symptomatology and Cognitive Impairment in Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Changes in PANSS negative subscore between memantine and placebo treatment [ Time Frame: during trial ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: November 2005
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: June 2012 (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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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)
Study First Received: September 7, 2005
Last Updated: February 10, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Memantine
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013