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Amantadine as Adjunctive Therapy to Antipsychotics in Schizophrenia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2011 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00999505
First Posted: October 21, 2009
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hospital de Clinicas de Porto Alegre
  Purpose
Amantadine as add-on therapy to antipsychotics may improve schizophrenia positive, negative and cognitive symptoms.

Condition Intervention Phase
Schizophrenia Drug: Amantadine Drug: Placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas de Porto Alegre:

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

Estimated Enrollment: 40
Study Start Date: May 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
  Contacts and Locations
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
  More Information

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 Submitted: October 20, 2009
First Posted: October 21, 2009
Last Update Posted: October 12, 2017
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