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OpenTrials
Completed

NCT Number: NCT00097942

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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Synergy Clinical Research, National City, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

memantine HCl

Drug

Primary outcomes

  1. Positive and Negative Symptom Scale (PANSS) - Total Score

Secondary outcomes

  1. Clinical Global Impression - Severity (CGI-S)

  2. PANNS - Positive Score

  3. PANSS - Negative Score

  4. Calgary Depression Scale for Schizophrenia

  5. Brief Assessment of Cognition

  6. Clinical Global Impression - Improvement

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Dec 2, 2004
Registry last updated
Mar 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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