Memantine as Adjunctive Therapy for Schizophrenia Negative Symptoms

NCT ID: NCT00757978

Last Updated: 2008-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-03-31

Brief Summary

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

Detailed Description

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Conditions

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Schizophrenia

Keywords

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Schizophrenia negative symptoms clozapine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Clozapine plus placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

1 capsule of placebo twice a day

2

Clozapine plus memantine

Group Type ACTIVE_COMPARATOR

memantine

Intervention Type DRUG

memantine 10mg twice a day

Interventions

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memantine

memantine 10mg twice a day

Intervention Type DRUG

placebo

1 capsule of placebo twice a day

Intervention Type DRUG

Other Intervention Names

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Ebixa Starch

Eligibility Criteria

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Inclusion Criteria

* Under clozapine with negative symptoms

Exclusion Criteria

* Pregnancy
* Lactation
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Hospital de Clinicas de Porto Alegre

Principal Investigators

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Clarissa S Gama, PhD

Role: STUDY_DIRECTOR

Hospital de Clinicas de Porto Alegre

Locations

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Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 19906345 (View on PubMed)

Other Identifiers

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FIPE-HCPA 05-406

Identifier Type: -

Identifier Source: secondary_id

05-406

Identifier Type: -

Identifier Source: org_study_id