Memantine as Adjunctive Therapy for Schizophrenia Negative Symptoms

This study has been completed.
Sponsor:
Information provided by:
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT00757978
First received: September 22, 2008
Last updated: December 17, 2008
Last verified: September 2008
  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 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

  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
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 by Hospital de Clinicas de Porto Alegre

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: FIPE, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov 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:
Schizophrenia
negative symptoms
clozapine

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

ClinicalTrials.gov processed this record on April 14, 2014