Amantadine as Adjunctive Therapy to Antipsychotics in Schizophrenia
A Double-blind, Randomized, Placebo-controlled Trial With Amantadine as Adjunctive Therapy to Antipsychotics in Schizophrenia
1 other identifier
interventional
40
1 country
1
Brief Summary
Amantadine as add-on therapy to antipsychotics may improve schizophrenia positive, negative and cognitive symptoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 schizophrenia
Started May 2010
Shorter than P25 for phase_3 schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2009
CompletedFirst Posted
Study publicly available on registry
October 21, 2009
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedFebruary 16, 2011
February 1, 2011
1.3 years
October 20, 2009
February 15, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Scores in Brief Psychiatric Rating Scale
Baseline, 4 weeks, 8 weeks, 12 weeks
Study Arms (2)
Amantadine
ACTIVE COMPARATORAmantadine 200mg twice a day
Placebo
PLACEBO COMPARATORPlacebo capsules twice a day
Interventions
Eligibility Criteria
You may qualify if:
- Under antipsychotics with residual symptoms
You may not qualify if:
- Pregnancy
- Lactation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Clarissa S Gama, MD, PhD
Hospital de Clinicas de Porto Alegre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 20, 2009
First Posted
October 21, 2009
Study Start
May 1, 2010
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
February 16, 2011
Record last verified: 2011-02