Evaluation of the Safety and Efficacy of Memantine as Adjunctive Treatment in Schizophrenia Patients - Full Text View

Purpose

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	Intervention	Phase
Schizophrenia	Drug: memantine HCl	Phase II

MedlinePlus related topics:

Schizophrenia

ChemIDplus related topics:

Memantine Memantine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	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

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:

Positive and Negative Symptom Scale (PANSS) - Total Score

Secondary Outcome Measures:

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

Estimated Enrollment:	128
Study Start Date:	August 2004

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00097942

Locations


United States, California
	VA San Diego Healthcare System
	San Diego, California, United States, 92161
	Synergy Clinical Research
	National City, California, United States, 91950

United States, Florida
	University of Miami Jackson Memorial Hospital
	Miami, Florida, United States, 33136

United States, Iowa
	University of Iowa Psychiatric Research
	Iowa City, Iowa, United States, 52242

United States, Maryland
	CBH Health, LLC
	Rockville, Maryland, United States, 20850

United States, Missouri
	Metropolitan Psychiatric Center
	St. Louis, Missouri, United States, 63112

United States, New Hampshire
	Dartmouth Hitchcock Medical School
	Lebanon, New Hampshire, United States, 03755

United States, New York
	Nathan Kline Institute
	Orangeburg, New York, United States, 10962

United States, North Carolina
	UNC - Chapel Hill, Clinical Research Unit
	Raleigh, North Carolina, United States, 27699-3601
	Duke University John Umstead Hospital
	Butner, North Carolina, United States, 27509

United States, Ohio
	University of Cincinnati Medical Science Building
	Cincinnati, Ohio, United States, 45267-0559

United States, Texas
	University Hills Clinical Research
	Irving, Texas, United States, 75062
	Medication Research Clinic
	San Antonio, Texas, United States, 78207

Sponsors and Collaborators

Forest Laboratories

More Information

Study ID Numbers:	MEM-MD-29
First Received:	December 1, 2004
Last Updated:	February 14, 2006
ClinicalTrials.gov Identifier:	NCT00097942
Health Authority:	United States: Food and Drug Administration

Keywords provided by Forest Laboratories:

memantine

adjunctive therapy

schizophrenia

Study placed in the following topic categories:

Schizophrenia

Excitatory Amino Acids

Dopamine

Mental Disorders

Memantine

Psychotic Disorders

Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Anti-Dyskinesia Agents

Therapeutic Uses

Physiological Effects of Drugs

Antiparkinson Agents

Excitatory Amino Acid Agents

Dopamine Agents

Central Nervous System Agents

Pharmacologic Actions

Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on September 04, 2008

Sponsored by:	Forest Laboratories
Information provided by:	Forest Laboratories
ClinicalTrials.gov Identifier:	NCT00097942