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

This study has been completed.
Sponsor:
Information provided by:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00097942
First received: December 1, 2004
Last updated: March 1, 2012
Last verified: March 2012
  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 2

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:


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

Enrollment: 138
Study Start Date: August 2004
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: March 1, 2012
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
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents

ClinicalTrials.gov processed this record on August 27, 2014