Official Title: “Phase 4 Memantine as Adjunctive Therapy for Schizophrenia Negative Symptoms in Patients Using Clozapine. A Randomized, Double-Blind, Placebo Controled Study”

Memantine as an add-on therapy to clozapine may improve schizophrenia negative symptoms and cognitive functioning.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2008

Intervention(s) in this Clinical Trial

• Drug: memantine
  • memantine 10mg twice a day
• Drug: placebo
  • 1 capsule of placebo twice a day

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 1
  • Clozapine plus placebo
• Active Comparator: 2
  • Clozapine plus memantine

Primary Measures

• Score in Brief Psychiatric Raring Scale
  • Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks
    Safety Issue?: No

Inclusion Criteria:

• Under clozapine with negative symptoms

Exclusion Criteria:

• Pregnancy
• Lactation

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Hospital de Clinicas de Porto Alegre

Overall Clinical Trial Officials and Contacts

Clarissa S Gama, PhD Study Director Hospital de Clinicas de Porto Alegre  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00757978

Study ID Number: 05-406

ClinicalTrials.gov Identifier: NCT00757978

Health Authority: Brazil: National Committee of Ethics in Research