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

This study has been completed.

First Received on December 1, 2004. Last Updated on February 14, 2006 History of Changes

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

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Memantine Memantine hydrochloride

U.S. FDA Resources

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
Synergy Clinical Research
National City, California, United States, 91950
VA San Diego Healthcare System
San Diego, California, United States, 92161
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
Duke University John Umstead Hospital
Butner, North Carolina, United States, 27509
UNC - Chapel Hill, Clinical Research Unit
Raleigh, North Carolina, United States, 27699-3601
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

No publications provided

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

Keywords provided by Forest Laboratories:

memantine
adjunctive therapy
schizophrenia

Additional relevant MeSH terms:

Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Memantine
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012