Memantine as Adjunctive Therapy for Schizophrenia Negative Symptoms

This study has been completed.

First Received: September 22, 2008 Last Updated: December 17, 2008 History of Changes

Sponsored by:	Hospital de Clinicas de Porto Alegre
Information provided by:	Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:	NCT00757978

Purpose

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

Condition	Intervention	Phase
Schizophrenia	Drug: memantine Drug: placebo	Phase IV

MedlinePlus related topics: Schizophrenia

Drug Information available for: Memantine Memantine hydrochloride Clozapine

U.S. FDA Resources

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

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
1: Placebo Comparator Clozapine plus placebo	Drug: placebo 1 capsule of placebo twice a day
2: Active Comparator Clozapine plus memantine	Drug: memantine memantine 10mg twice a day

Eligibility

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

Criteria

Inclusion Criteria:

Under clozapine with negative symptoms

Exclusion Criteria:

Pregnancy
Lactation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00757978

Locations

Brazil, RS
Hospital de Clinicas de Porto Alegre
Porto Alegre, RS, Brazil, 90035-903

Sponsors and Collaborators

Hospital de Clinicas de Porto Alegre

Investigators

Study Director:

Clarissa S Gama, PhD

Hospital de Clinicas de Porto Alegre

More Information

No publications provided

Responsible Party:	Hospital de Clinicas de Porto Alegre ( FIPE )
Study ID Numbers:	05-406, FIPE-HCPA 05-406
Study First Received:	September 22, 2008
Last Updated:	December 17, 2008
ClinicalTrials.gov Identifier:	NCT00757978 History of Changes
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by Hospital de Clinicas de Porto Alegre:

Schizophrenia
negative symptoms
clozapine

Study placed in the following topic categories:

Schizophrenia
Excitatory Amino Acids
Neurotransmitter Agents
Dopamine
Mental Disorders

Clozapine
Memantine
Dopamine Agents
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Antiparkinson Agents
Excitatory Amino Acid Agents
Pharmacologic Actions
Schizophrenia

Mental Disorders
Therapeutic Uses
Memantine
Dopamine Agents
Central Nervous System Agents
Schizophrenia and Disorders with Psychotic Features
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on May 07, 2009