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Memantine as Adjunctive Therapy for Schizophrenia Negative Symptoms

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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

September 22, 2008
September 23, 2008
December 18, 2008
January 2006
January 2008   (Final data collection date for primary outcome measure)
Score in Brief Psychiatric Raring Scale [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ]
Same as current
Complete list of historical versions of study NCT00757978 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Memantine as Adjunctive Therapy for Schizophrenia Negative Symptoms
Phase 4 Memantine as Adjunctive Therapy for Schizophrenia Negative Symptoms in Patients Using Clozapine. A Randomized, Double-Blind, Placebo Controled Study
Memantine as an add-on therapy to clozapine may improve schizophrenia negative symptoms and cognitive functioning.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • Drug: memantine
    memantine 10mg twice a day
    Other Name: Ebixa
  • Drug: placebo
    1 capsule of placebo twice a day
    Other Name: Starch
  • Placebo Comparator: 1
    Clozapine plus placebo
    Intervention: Drug: placebo
  • Active Comparator: 2
    Clozapine plus memantine
    Intervention: Drug: memantine
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
Same as current
March 2008
January 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Under clozapine with negative symptoms

Exclusion Criteria:

  • Pregnancy
  • Lactation
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT00757978
05-406
FIPE-HCPA 05-406
No
Not Provided
Not Provided
FIPE, Hospital de Clinicas de Porto Alegre
Hospital de Clinicas de Porto Alegre
Not Provided
Study Director: Clarissa S Gama, PhD Hospital de Clinicas de Porto Alegre
Hospital de Clinicas de Porto Alegre
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP