Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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:


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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: October 17, 2013
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
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Memantine
Anti-Dyskinesia Agents
Antiparkinson Agents
Central Nervous System Agents
Dopamine Agents
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014