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

NCT ID: NCT00097942

Last Updated: 2012-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2005-09-30

Brief Summary

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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

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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memantine HCl

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Forest Laboratories

INDUSTRY

Sponsor Role lead

Locations

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Synergy Clinical Research

National City, California, United States

Site Status

VA San Diego Healthcare System

San Diego, California, United States

Site Status

University of Miami Jackson Memorial Hospital

Miami, Florida, United States

Site Status

University of Iowa Psychiatric Research

Iowa City, Iowa, United States

Site Status

CBH Health, LLC

Rockville, Maryland, United States

Site Status

Metropolitan Psychiatric Center

St Louis, Missouri, United States

Site Status

Dartmouth Hitchcock Medical School

Lebanon, New Hampshire, United States

Site Status

Nathan Kline Institute

Orangeburg, New York, United States

Site Status

Duke University John Umstead Hospital

Butner, North Carolina, United States

Site Status

UNC - Chapel Hill, Clinical Research Unit

Raleigh, North Carolina, United States

Site Status

University of Cincinnati Medical Science Building

Cincinnati, Ohio, United States

Site Status

University Hills Clinical Research

Irving, Texas, United States

Site Status

Medication Research Clinic

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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MEM-MD-29

Identifier Type: -

Identifier Source: org_study_id

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