Memantine for the Treatment 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:
NCT00148616
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 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 Intervention Phase
Chronic Schizophrenia
Drug: Memantine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Memantine for the Treatment 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: April 2004
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 dosage of 10mg Memantine vs. Placebo
Other Name: Akatinol
Placebo Comparator: Placebo Drug: Memantine
Daily dosage of 10mg Memantine vs. Placebo
Other Name: Akatinol

  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
  • 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
  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: 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
  More Information

No publications provided

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)
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

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

ClinicalTrials.gov processed this record on October 01, 2014