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

Forest Laboratories

Status and phase: Completed; Phase 2

Conditions: Schizophrenia

Treatments: Drug: memantine HCl

Study type: Interventional

Funder types: Industry

Identifiers

NCT00097942

MEM-MD-29

Details and patient eligibility

About

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.

Enrollment: 138 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind