Evaluation of the Safety and Efficacy of Memantine as Adjunctive Treatment in Schizophrenia Patients
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
1 other identifier
interventional
138
1 country
13
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 schizophrenia
Started Aug 2004
Shorter than P25 for phase_2 schizophrenia
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
December 1, 2004
CompletedFirst Posted
Study publicly available on registry
December 2, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2005
CompletedMarch 5, 2012
March 1, 2012
1.1 years
December 1, 2004
March 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Positive and Negative Symptom Scale (PANSS) - Total Score
Secondary Outcomes (6)
Clinical Global Impression - Severity (CGI-S)
PANNS - Positive Score
PANSS - Negative Score
Calgary Depression Scale for Schizophrenia
Brief Assessment of Cognition
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Secondary diagnosis of Bipolar I disorder
- Suicidal history
- Organic brain disease
- Dementia
- History of substance abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Synergy Clinical Research
National City, California, 91950, United States
VA San Diego Healthcare System
San Diego, California, 92161, United States
University of Miami Jackson Memorial Hospital
Miami, Florida, 33136, United States
University of Iowa Psychiatric Research
Iowa City, Iowa, 52242, United States
CBH Health, LLC
Rockville, Maryland, 20850, United States
Metropolitan Psychiatric Center
St Louis, Missouri, 63112, United States
Dartmouth Hitchcock Medical School
Lebanon, New Hampshire, 03755, United States
Nathan Kline Institute
Orangeburg, New York, 10962, United States
Duke University John Umstead Hospital
Butner, North Carolina, 27509, United States
UNC - Chapel Hill, Clinical Research Unit
Raleigh, North Carolina, 27699-3601, United States
University of Cincinnati Medical Science Building
Cincinnati, Ohio, 45267-0559, United States
University Hills Clinical Research
Irving, Texas, 75062, United States
Medication Research Clinic
San Antonio, Texas, 78207, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 1, 2004
First Posted
December 2, 2004
Study Start
August 1, 2004
Primary Completion
September 1, 2005
Study Completion
September 1, 2005
Last Updated
March 5, 2012
Record last verified: 2012-03