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Memantine as Adjunctive Therapy for Schizophrenia Negative Symptoms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00757978
Recruitment Status : Completed
First Posted : September 23, 2008
Last Update Posted : December 18, 2008
Sponsor:
Information provided by:
Hospital de Clinicas de Porto Alegre

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

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: memantine Drug: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : January 2006
Actual Primary Completion Date : January 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Score in Brief Psychiatric Raring Scale [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Under clozapine with negative symptoms

Exclusion Criteria:

  • Pregnancy
  • Lactation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00757978


Locations
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Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, RS, Brazil, 90035-903
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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Study Director: Clarissa S Gama, PhD Hospital de Clinicas de Porto Alegre
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: FIPE, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT00757978    
Other Study ID Numbers: 05-406
FIPE-HCPA 05-406
First Posted: September 23, 2008    Key Record Dates
Last Update Posted: December 18, 2008
Last Verified: September 2008
Keywords provided by Hospital de Clinicas de Porto Alegre:
Schizophrenia
negative symptoms
clozapine
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Memantine
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents