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Memantine for the Treatment of Negative Symptomatology

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ClinicalTrials.gov Identifier: NCT00148616
Recruitment Status : Terminated
First Posted : September 8, 2005
Last Update Posted : October 18, 2013
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
M. Schaefer, MD, Charite University, Berlin, Germany

Brief Summary:

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


Condition or disease Intervention/treatment Phase
Chronic Schizophrenia Drug: Memantine Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Memantine for the Treatment of Negative Symptomatology and Cognitive Impairment in Schizophrenia
Study Start Date : April 2004
Actual Primary Completion Date : June 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1 Drug: Memantine
Daily dosage of 10mg Memantine vs. Placebo
Other Name: Akatinol
Placebo Comparator: Placebo Drug: Memantine
Daily dosage of 10mg Memantine vs. Placebo
Other Name: Akatinol



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


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
  • 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

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): NCT00148616


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

Responsible Party: M. Schaefer, MD, Professor of Psychiatry, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00148616     History of Changes
Other Study ID Numbers: MIND 2
02T-247 (SMRI)
First Posted: September 8, 2005    Key Record Dates
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

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