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Memantine for the Treatment 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:
NCT00148616
First received: September 7, 2005
Last updated: February 10, 2012
Last verified: February 2012
History of Changes

September 7, 2005
February 10, 2012
April 2004
June 2012   (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 NCT00148616 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Memantine for the Treatment of Negative Symptomatology
Memantine for the Treatment 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 treatment of negative symptomatology and cognitive impairment in patients with chronic schizophrenia.

Primary outcome parameter are changes in negative symptoms between baseline and 6 months
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Chronic Schizophrenia
Drug: Memantine
Daily dosage of 10mg Memantine vs. Placebo
Other Name: Akatinol
  • Active Comparator: 1
    Intervention: Drug: Memantine
  • Placebo Comparator: Placebo
    Intervention: Drug: Memantine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
July 2012
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of schizophrenia (DSM-IV)
  • Age 18 to 40
  • Stable negative syndrome (PANSS negative score > 20)
  • At least one previous schizophrenic episode
  • Informed consent
  • Subjects must be considered by the investigator to be compliant with investigations and appointments
  • 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 positive symptomatology (PANNS positive score > PANNS negative score)
  • 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
Both
18 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00148616
MIND 2, 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
February 2012

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