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Amantadine as Adjunctive Therapy to Antipsychotics in Schizophrenia

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ClinicalTrials.gov Identifier: NCT00999505
Recruitment Status : Unknown
Verified February 2011 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Recruiting
First Posted : October 21, 2009
Last Update Posted : February 16, 2011
Sponsor:
Information provided by:
Hospital de Clinicas de Porto Alegre

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

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Amantadine Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Placebo-controlled Trial With Amantadine as Adjunctive Therapy to Antipsychotics in Schizophrenia
Study Start Date : May 2010
Estimated Primary Completion Date : September 2011
Estimated Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Amantadine
Amantadine 200mg twice a day
Drug: Amantadine
Amantadine 200mg twice a day over 12 weeks
Other Name: Mantidan TM
Placebo Comparator: Placebo
Placebo capsules twice a day
Drug: Placebo
Placebo capsules twice a day over 12 weeks



Primary Outcome Measures :
  1. Scores in Brief Psychiatric Rating Scale [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Under antipsychotics with residual symptoms

Exclusion Criteria:

  • Pregnancy
  • Lactation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00999505


Contacts
Contact: Clarissa S Gama, MD, PhD 55-51-33598745 csgama@yahoo.com

Locations
Brazil
Hospital de Clinicas de Porto Alegre Recruiting
Porto Alegre, RS, Brazil, 90035-903
Sub-Investigator: David Lucena, MD         
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Principal Investigator: Clarissa S Gama, MD, PhD Hospital de Clinicas de Porto Alegre

Responsible Party: Clarissa Severino Gama, MD, PhD, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT00999505     History of Changes
Other Study ID Numbers: 09-303
First Posted: October 21, 2009    Key Record Dates
Last Update Posted: February 16, 2011
Last Verified: February 2011

Keywords provided by Hospital de Clinicas de Porto Alegre:
Schizophrenia
Amantadine
Residual symptoms

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Amantadine
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Antiviral Agents
Anti-Infective Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents