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

Forest Laboratories138 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

138

Conditions

Schizophrenia

Interventions

memantine HClDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (13)

Synergy Clinical Research

National City, California, United States

VA San Diego Healthcare System

San Diego, California, United States

University of Miami Jackson Memorial Hospital

Miami, Florida, United States

Outcomes

Primary Outcomes

Positive and Negative Symptom Scale (PANSS) - Total Score

Secondary Outcomes

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

Data from ClinicalTrials.gov

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