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Evaluation of the Safety and Efficacy of Memantine as Adjunctive Treatment in Schizophrenia Patients

This study has been completed.

Sponsored by: Forest Laboratories
Information provided by: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00097942
  Purpose

Standard antipsychotic drug regimens do not fully address the impact of cognitive symptoms associated with schizophrenia. The NMDA receptor has been connected to the pathophysiology of schizophrenia. Memantine is an uncompetitive NMDA receptor antagonist. It is hypothesized that adjunctive therapy with memantine will reduce NMDA receptor hyperactivity, improving signal to noise ratio and thereby improving cognitive symptoms.


Condition Intervention Phase
Schizophrenia
Drug: memantine HCl
Phase II

MedlinePlus related topics:   Schizophrenia   

ChemIDplus related topics:   Memantine    Memantine hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Memantine as Adjunctive Treatment to Atypical Antipsychotics in Schizophrenia Patients With Persistent Residual Symptoms

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Positive and Negative Symptom Scale (PANSS) - Total Score

Secondary Outcome Measures:
  • Clinical Global Impression - Severity (CGI-S)
  • PANNS - Positive Score
  • PANSS - Negative Score
  • Calgary Depression Scale for Schizophrenia
  • Brief Assessment of Cognition
  • Clinical Global Impression - Improvement

Estimated Enrollment:   128
Study Start Date:   August 2004

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • DSM-IV diagnosed Schizophrenia or schizoaffective disorder who are on a stable antipsychotic regimen with Brief Psychiatric Rating Scale (BPRS) total score greater than or equal to 26 and greater than or equal to 4 on at least one item

Exclusion Criteria:

  • Secondary diagnosis of Bipolar I disorder
  • Suicidal history
  • Organic brain disease
  • Dementia
  • History of substance abuse
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00097942

Locations
United States, California
VA San Diego Healthcare System    
      San Diego, California, United States, 92161
Synergy Clinical Research    
      National City, California, United States, 91950
United States, Florida
University of Miami Jackson Memorial Hospital    
      Miami, Florida, United States, 33136
United States, Iowa
University of Iowa Psychiatric Research    
      Iowa City, Iowa, United States, 52242
United States, Maryland
CBH Health, LLC    
      Rockville, Maryland, United States, 20850
United States, Missouri
Metropolitan Psychiatric Center    
      St. Louis, Missouri, United States, 63112
United States, New Hampshire
Dartmouth Hitchcock Medical School    
      Lebanon, New Hampshire, United States, 03755
United States, New York
Nathan Kline Institute    
      Orangeburg, New York, United States, 10962
United States, North Carolina
UNC - Chapel Hill, Clinical Research Unit    
      Raleigh, North Carolina, United States, 27699-3601
Duke University John Umstead Hospital    
      Butner, North Carolina, United States, 27509
United States, Ohio
University of Cincinnati Medical Science Building    
      Cincinnati, Ohio, United States, 45267-0559
United States, Texas
University Hills Clinical Research    
      Irving, Texas, United States, 75062
Medication Research Clinic    
      San Antonio, Texas, United States, 78207

Sponsors and Collaborators
Forest Laboratories
  More Information

Study ID Numbers:   MEM-MD-29
First Received:   December 1, 2004
Last Updated:   February 14, 2006
ClinicalTrials.gov Identifier:   NCT00097942
Health Authority:   United States: Food and Drug Administration

Keywords provided by Forest Laboratories:
memantine  
adjunctive therapy  
schizophrenia  

Study placed in the following topic categories:
Schizophrenia
Excitatory Amino Acids
Dopamine
Mental Disorders
Memantine
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Therapeutic Uses
Physiological Effects of Drugs
Antiparkinson Agents
Excitatory Amino Acid Agents
Dopamine Agents
Central Nervous System Agents
Pharmacologic Actions
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on September 04, 2008




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