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	Treatment or Intervention	Phase
Schizophrenia	Drug: memantine HCl	Phase II

Further Study Details: 

Primary Outcomes: Postive and Negative Symptom Scale (PANSS) - Total Score
Secondary Outcomes: Clinical Global Impression - Severity (CGI-S); PANNS - Postive Score; PANSS - Negative Score; Calgary Depression Scale for Schizophrenia; Brief Assessment of Cognition; Clinical Global Impression - Improvement
Expected Total Enrollment:  128

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

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

California
      VA San Diego Healthcare System, San Diego,  California,  92161,  United States; Recruiting
      Synergy Clinical Research, San Diego,  California,  92405,  United States; Recruiting
Florida
      University of Miami Jackson Memorial Hospital, Miami,  Florida,  33136,  United States; Recruiting
Iowa
      University of Iowa Psychiatric Research, Iowa City,  Iowa,  52242,  United States; Recruiting
Maryland
      Centers for Behavioral Health, Rockville,  Maryland,  20850,  United States; Recruiting
Missouri
      Metropolitan Psychiatric Center, St. Louis,  Missouri,  63112,  United States; Recruiting
New Hampshire
      Dartmouth Hitchcock Medical School, Lebanon,  New Hampshire,  03755,  United States; Recruiting
New York
      Nathan Kline Institute, Orangeburg,  New York,  10962,  United States; Recruiting
North Carolina
      UNC - Chapel Hill, Clinical Research Unit, Raleigh,  North Carolina,  27699-3601,  United States; Recruiting
      Duke University John Umstead Hospital, Butner,  North Carolina,  27509,  United States; Recruiting
Ohio
      University of Cincinnati Medical Science Building, Cincinnati,  Ohio,  45267-0559,  United States; Recruiting
Texas
      University of Texas at San Antonio, Dept. Psychiatry, San Antonio,  Texas,  78229-3900,  United States; Recruiting
      University Hills Clinical Research, Irving,  Texas,  75062,  United States; Recruiting

Study ID Numbers:  MEM-MD-29
Record last reviewed:  January 2005
Last Updated:  January 28, 2005
Record first received:  December 1, 2004
ClinicalTrials.gov Identifier:  NCT00097942
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08