Amantadine as Adjunctive Therapy to Antipsychotics in Schizophrenia

February 15, 2011 updated by: Hospital de Clinicas de Porto Alegre

A Double-blind, Randomized, Placebo-controlled Trial With Amantadine as Adjunctive Therapy to Antipsychotics in Schizophrenia

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Clarissa S Gama, MD, PhD
  • Phone Number: 55-51-33598745
  • Email: csgama@yahoo.com

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90035-903
        • Recruiting
        • Hospital de Clinicas de Porto Alegre
        • Sub-Investigator:
          • David Lucena, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Under antipsychotics with residual symptoms

Exclusion Criteria:

  • Pregnancy
  • Lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Amantadine
Amantadine 200mg twice a day
Drug: Amantadine
Amantadine 200mg twice a day over 12 weeks
Other Names:
  • Mantidan TM
Placebo Comparator: Placebo
Placebo capsules twice a day
Drug: Placebo
Placebo capsules twice a day over 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Scores in Brief Psychiatric Rating Scale
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Baseline, 4 weeks, 8 weeks, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

  • Principal Investigator: Clarissa S Gama, MD, PhD, Hospital de Clinicas de Porto Alegre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Anticipated)

September 1, 2011

Study Completion (Anticipated)

September 1, 2011

Study Registration Dates

First Submitted

October 20, 2009

First Submitted That Met QC Criteria

October 20, 2009

First Posted (Estimate)

October 21, 2009

Study Record Updates

Last Update Posted (Estimate)

February 16, 2011

Last Update Submitted That Met QC Criteria

February 15, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-303

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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