Back to resultsAmantadine as Adjunctive Therapy to Antipsychotics in Schizophrenia
Primary Purpose
Schizophrenia
Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Amantadine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Amantadine, Residual symptoms
Eligibility Criteria
Inclusion Criteria:
- Under antipsychotics with residual symptoms
Exclusion Criteria:
- Pregnancy
- Lactation
Sites / Locations
- Hospital de Clinicas de Porto AlegreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Amantadine
Placebo
Arm Description
Amantadine 200mg twice a day
Placebo capsules twice a day
Outcomes
Primary Outcome Measures
Scores in Brief Psychiatric Rating Scale
Secondary Outcome Measures
Full Information
NCT ID
NCT00999505
First Posted
October 20, 2009
Last Updated
February 15, 2011
Sponsor
Hospital de Clinicas de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT00999505
Brief Title
Amantadine as Adjunctive Therapy to Antipsychotics in Schizophrenia
Official Title
A Double-blind, Randomized, Placebo-controlled Trial With Amantadine as Adjunctive Therapy to Antipsychotics in Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
May 2010 (undefined)
Primary Completion Date
September 2011 (Anticipated)
Study Completion Date
September 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Amantadine as add-on therapy to antipsychotics may improve schizophrenia positive, negative and cognitive symptoms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Amantadine, Residual symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Amantadine
Arm Type
Active Comparator
Arm Description
Amantadine 200mg twice a day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsules twice a day
Intervention Type
Drug
Intervention Name(s)
Amantadine
Other Intervention Name(s)
Mantidan TM
Intervention Description
Amantadine 200mg twice a day over 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsules twice a day over 12 weeks
Primary Outcome Measure Information:
Title
Scores in Brief Psychiatric Rating Scale
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Under antipsychotics with residual symptoms
Exclusion Criteria:
Pregnancy
Lactation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clarissa S Gama, MD, PhD
Phone
55-51-33598745
Email
csgama@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clarissa S Gama, MD, PhD
Organizational Affiliation
Hospital de Clinicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-903
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Lucena, MD
12. IPD Sharing Statement
Learn more about this trial
Amantadine as Adjunctive Therapy to Antipsychotics in Schizophrenia
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