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

Tracking Information
First Received Date ^ICMJE	December 1, 2004
Last Updated Date	February 14, 2006
Start Date ^ICMJE	August 2004
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: June 23, 2005)	Positive and Negative Symptom Scale (PANSS) - Total Score
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00097942 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 23, 2005)	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
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Evaluation of the Safety and Efficacy of Memantine as Adjunctive Treatment in Schizophrenia Patients
Official Title ^ICMJE	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
Brief Summary	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.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Schizophrenia
Intervention ^ICMJE	Drug: memantine HCl
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	128
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00097942
Responsible Party
Study ID Numbers ^ICMJE	MEM-MD-29
Study Sponsor ^ICMJE	Forest Laboratories
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Forest Laboratories
Verification Date	February 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP