Memantine as Adjunctive Therapy for Schizophrenia Negative Symptoms

December 17, 2008 updated by: Hospital de Clinicas de Porto Alegre

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90035-903
        • Hospital de Clínicas de Porto Alegre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Under clozapine with negative symptoms

Exclusion Criteria:

  • Pregnancy
  • Lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Clozapine plus placebo
Drug: placebo
1 capsule of placebo twice a day
Other Names:
  • Starch
Active Comparator: 2
Clozapine plus memantine
Drug: memantine
memantine 10mg twice a day
Other Names:
  • Ebixa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Score in Brief Psychiatric Raring Scale
Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks
baseline, 4 weeks, 8 weeks, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

  • Study Director: Clarissa S Gama, PhD, Hospital de Clínicas de Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

September 22, 2008

First Submitted That Met QC Criteria

September 22, 2008

First Posted (Estimate)

September 23, 2008

Study Record Updates

Last Update Posted (Estimate)

December 18, 2008

Last Update Submitted That Met QC Criteria

December 17, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-406
  • FIPE-HCPA 05-406

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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