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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00097942
Enrollment
138
Registered
2004-12-02
Start date
2004-08-31
Completion date
2005-09-30
Last updated
2012-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

memantine, adjunctive therapy, schizophrenia

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.

Interventions

Sponsors

Forest Laboratories
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Positive and Negative Symptom Scale (PANSS) - Total Score

Secondary

MeasureTime frame
PANNS - Positive Score
PANSS - Negative Score
Clinical Global Impression - Severity (CGI-S)
Brief Assessment of Cognition
Clinical Global Impression - Improvement
Calgary Depression Scale for Schizophrenia

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026