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Evaluation of the Safety and Efficacy of Memantine as Adjunctive Treatment in Schizophrenia Patients
This study has been completed.
Sponsor:
Forest Laboratories
Information provided by:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00097942
First received: December 1, 2004
Last updated: March 1, 2012
Last verified: March 2012
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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 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:
Genetics Home Reference related topics:
schizophrenia
MedlinePlus related topics:
Schizophrenia
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
| 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 (Adult) |
| Sexes Eligible for Study: | All |
| 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
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
| 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 |
Keywords provided by Forest Laboratories:
|
memantine adjunctive therapy schizophrenia |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Memantine Antiparkinson Agents Anti-Dyskinesia Agents |
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 July 18, 2017