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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

October 20, 2009
October 21, 2009
February 16, 2011
May 2010
September 2011   (Final data collection date for primary outcome measure)
Scores in Brief Psychiatric Rating Scale [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks ]
Same as current
Complete list of historical versions of study NCT00999505 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Amantadine as Adjunctive Therapy to Antipsychotics in Schizophrenia
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • Drug: Amantadine
    Amantadine 200mg twice a day over 12 weeks
    Other Name: Mantidan TM
  • Drug: Placebo
    Placebo capsules twice a day over 12 weeks
  • Active Comparator: Amantadine
    Amantadine 200mg twice a day
    Intervention: Drug: Amantadine
  • Placebo Comparator: Placebo
    Placebo capsules twice a day
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
40
Same as current
September 2011
September 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Under antipsychotics with residual symptoms

Exclusion Criteria:

  • Pregnancy
  • Lactation
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT00999505
09-303
09-303
No
Not Provided
Not Provided
Clarissa Severino Gama, MD, PhD, Hospital de Clinicas de Porto Alegre
Hospital de Clinicas de Porto Alegre
Not Provided
Principal Investigator: Clarissa S Gama, MD, PhD Hospital de Clinicas de Porto Alegre
Hospital de Clinicas de Porto Alegre
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP