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

Phase 2

Completed

• Conditions: Schizophrenia

• Registration Number: NCT00097942
• Lead Sponsor: Forest Laboratories

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2004-12-01
• Study First Submitted QC: 2004-12-01
• Study First Posted: 2004-12-02
• Primary Completion: 2005-09
• Study Completion: 2005-09
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-01
• Last Update Posted: 2012-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Positive and Negative Symptom Scale (PANSS) - Total Score

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (13)

Synergy Clinical Research; 🇺🇸 National City, California, United States

VA San Diego Healthcare System; 🇺🇸 San Diego, California, United States

University of Miami Jackson Memorial Hospital; 🇺🇸 Miami, Florida, United States

University of Iowa Psychiatric Research; 🇺🇸 Iowa City, Iowa, United States

CBH Health, LLC; 🇺🇸 Rockville, Maryland, United States

Metropolitan Psychiatric Center; 🇺🇸 St. Louis, Missouri, United States

Dartmouth Hitchcock Medical School; 🇺🇸 Lebanon, New Hampshire, United States

Nathan Kline Institute; 🇺🇸 Orangeburg, New York, United States

Duke University John Umstead Hospital; 🇺🇸 Butner, North Carolina, United States

UNC - Chapel Hill, Clinical Research Unit; 🇺🇸 Raleigh, North Carolina, United States

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