Back to resultsMemantine as Adjunctive Therapy for Schizophrenia Negative Symptoms
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
memantine
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, negative symptoms, clozapine
Eligibility Criteria
Inclusion Criteria:
- Under clozapine with negative symptoms
Exclusion Criteria:
- Pregnancy
- Lactation
Sites / Locations
- Hospital de Clinicas de Porto Alegre
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
1
2
Arm Description
Clozapine plus placebo
Clozapine plus memantine
Outcomes
Primary Outcome Measures
Score in Brief Psychiatric Raring Scale
Secondary Outcome Measures
Full Information
NCT ID
NCT00757978
First Posted
September 22, 2008
Last Updated
December 17, 2008
Sponsor
Hospital de Clinicas de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT00757978
Brief Title
Memantine as Adjunctive Therapy for Schizophrenia Negative Symptoms
Official Title
Phase 4 Memantine as Adjunctive Therapy for Schizophrenia Negative Symptoms in Patients Using Clozapine. A Randomized, Double-Blind, Placebo Controled Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Memantine as an add-on therapy to clozapine may improve schizophrenia negative symptoms and cognitive functioning.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, negative symptoms, clozapine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Clozapine plus placebo
Arm Title
2
Arm Type
Active Comparator
Arm Description
Clozapine plus memantine
Intervention Type
Drug
Intervention Name(s)
memantine
Other Intervention Name(s)
Ebixa
Intervention Description
memantine 10mg twice a day
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
Starch
Intervention Description
1 capsule of placebo twice a day
Primary Outcome Measure Information:
Title
Score in Brief Psychiatric Raring Scale
Time Frame
baseline, 4 weeks, 8 weeks, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Under clozapine with negative symptoms
Exclusion Criteria:
Pregnancy
Lactation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clarissa S Gama, PhD
Organizational Affiliation
Hospital de Clinicas de Porto Alegre
Official's Role
Study Director
Facility Information:
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-903
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
19906345
Citation
de Lucena D, Fernandes BS, Berk M, Dodd S, Medeiros DW, Pedrini M, Kunz M, Gomes FA, Giglio LF, Lobato MI, Belmonte-de-Abreu PS, Gama CS. Improvement of negative and positive symptoms in treatment-refractory schizophrenia: a double-blind, randomized, placebo-controlled trial with memantine as add-on therapy to clozapine. J Clin Psychiatry. 2009 Oct;70(10):1416-23. doi: 10.4088/JCP.08m04935gry. Erratum In: J Clin Psychiatry. 2011 Aug;72(8):1157.
Results Reference
derived
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Memantine as Adjunctive Therapy for Schizophrenia Negative Symptoms
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