NCT00757978

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_4 schizophrenia

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2008

Completed
Last Updated

December 18, 2008

Status Verified

September 1, 2008

Enrollment Period

2 years

First QC Date

September 22, 2008

Last Update Submit

December 17, 2008

Conditions

Schizophrenia

Keywords

Schizophrenianegative symptomsclozapine

Outcome Measures

Primary Outcomes (1)

  • Score in Brief Psychiatric Raring Scale

    baseline, 4 weeks, 8 weeks, 12 weeks

Study Arms (2)

1

PLACEBO COMPARATOR

Clozapine plus placebo

Drug: placebo

2

ACTIVE COMPARATOR

Clozapine plus memantine

Drug: memantine

Interventions

memantineDRUG

memantine 10mg twice a day

Also known as: Ebixa
2
placeboDRUG

1 capsule of placebo twice a day

Also known as: Starch
1

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Under clozapine with negative symptoms

You may not qualify if:

  • Pregnancy
  • Lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 19906345DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

MemantineStarch

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AmantadineAdamantaneBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsGlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesPolysaccharides

Study Officials

  • Clarissa S Gama, PhD

    Hospital de Clinicas de Porto Alegre

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 22, 2008

First Posted

September 23, 2008

Study Start

January 1, 2006

Primary Completion

January 1, 2008

Study Completion

March 1, 2008

Last Updated

December 18, 2008

Record last verified: 2008-09

Locations

BR(1)