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

March 1, 2012 updated by: Forest Laboratories

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

138

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Positive and Negative Symptom Scale (PANSS) - Total Score

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forest Laboratories

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (Actual)

September 1, 2005

Study Completion (Actual)

September 1, 2005

Study Registration Dates

First Submitted

December 1, 2004

First Submitted That Met QC Criteria

December 1, 2004

First Posted (Estimate)

December 2, 2004

Study Record Updates

Last Update Posted (Estimate)

March 5, 2012

Last Update Submitted That Met QC Criteria

March 1, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEM-MD-29

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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