Amantadine as Adjunctive Therapy to Antipsychotics in Schizophrenia

NCT ID: NCT00999505

Last Updated: 2011-02-16

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-09-30

Brief Summary

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Amantadine as add-on therapy to antipsychotics may improve schizophrenia positive, negative and cognitive symptoms.

Detailed Description

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Conditions

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Schizophrenia

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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Amantadine

Amantadine 200mg twice a day

Group Type ACTIVE_COMPARATOR

Amantadine

Intervention Type DRUG

Amantadine 200mg twice a day over 12 weeks

Placebo

Placebo capsules twice a day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo capsules twice a day over 12 weeks

Interventions

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Amantadine

Amantadine 200mg twice a day over 12 weeks

Intervention Type DRUG

Placebo

Placebo capsules twice a day over 12 weeks

Intervention Type DRUG

Other Intervention Names

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Mantidan TM

Eligibility Criteria

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Inclusion Criteria

* Under antipsychotics with residual 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, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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 RECRUITING

Countries

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Brazil

Central Contacts

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Clarissa S Gama, MD, PhD

Role: CONTACT

55-51-33598745

Other Identifiers

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09-303

Identifier Type: -

Identifier Source: secondary_id

09-303

Identifier Type: -

Identifier Source: org_study_id

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