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Trial record 1 of 1 for:    NCT00757978
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Memantine as Adjunctive Therapy for Schizophrenia Negative Symptoms

This study has been completed.
Information provided by:
Hospital de Clinicas de Porto Alegre Identifier:
First received: September 22, 2008
Last updated: December 17, 2008
Last verified: September 2008

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

Condition Intervention Phase
Drug: memantine
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 4 Memantine as Adjunctive Therapy for Schizophrenia Negative Symptoms in Patients Using Clozapine. A Randomized, Double-Blind, Placebo Controled Study

Resource links provided by NLM:

Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • Score in Brief Psychiatric Raring Scale [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: January 2006
Study Completion Date: March 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Clozapine plus placebo
Drug: placebo
1 capsule of placebo twice a day
Other Name: Starch
Active Comparator: 2
Clozapine plus memantine
Drug: memantine
memantine 10mg twice a day
Other Name: Ebixa


Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Under clozapine with negative symptoms

Exclusion Criteria:

  • Pregnancy
  • Lactation
  Contacts and Locations
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Please refer to this study by its identifier: NCT00757978

Hospital de Clinicas de Porto Alegre
Porto Alegre, RS, Brazil, 90035-903
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Study Director: Clarissa S Gama, PhD Hospital de Clinicas de Porto Alegre
  More Information

No publications provided by Hospital de Clinicas de Porto Alegre

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: FIPE, Hospital de Clinicas de Porto Alegre Identifier: NCT00757978     History of Changes
Other Study ID Numbers: 05-406, FIPE-HCPA 05-406
Study First Received: September 22, 2008
Last Updated: December 17, 2008
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Hospital de Clinicas de Porto Alegre:
negative symptoms

Additional relevant MeSH terms:
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Anti-Dyskinesia Agents
Antiparkinson Agents
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
GABA Agents
GABA Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents processed this record on November 20, 2014