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Memantine for the Prevention of Negative Symptomatology

This study has been terminated.
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: October 17, 2013
Last verified: October 2013

September 7, 2005
October 17, 2013
November 2005
June 2008   (final data collection date for primary outcome measure)
Changes in PANSS negative subscore between memantine and placebo treatment [ Time Frame: during trial ] [ Designated as safety issue: No ]
Changes in PANSS negative subscore between memantine and placebo treatment
Complete list of historical versions of study NCT00148590 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Memantine for the Prevention of Negative Symptomatology
Memantine for the Prevention of Negative Symptomatology and Cognitive Impairment in Schizophrenia

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Schizophrenia
  • Drug: Memantine
    Daily dose of 10mg memantine Vs. Placebo
    Other Name: Akatinol
  • Drug: Placebo
    Daily dose of 10mg memantine Vs. Placebo
  • Active Comparator: 1
    Intervention: Drug: Memantine
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
40
December 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00148590
MIND 1, 02T-247 (SMRI)
Yes
M. Schaefer, MD, Charite University, Berlin, Germany
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
Charite University, Berlin, Germany
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP