Text Size

Amantadine as Adjunctive Therapy to Antipsychotics in Schizophrenia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Hospital de Clinicas de Porto Alegre.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT00999505
First received: October 20, 2009
Last updated: February 15, 2011
Last verified: February 2011
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Under antipsychotics with residual symptoms

Exclusion Criteria:

  • Pregnancy
  • Lactation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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, 09-303
Study First Received: October 20, 2009
Last Updated: February 15, 2011
Health Authority: Brazil: National Committee of Ethics in Research

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

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

ClinicalTrials.gov processed this record on June 17, 2013