Amantadine as Adjunctive Therapy to Antipsychotics in Schizophrenia

Schizophrenia Clinical Trial

Official title:

A Double-blind, Randomized, Placebo-controlled Trial With Amantadine as Adjunctive Therapy to Antipsychotics in Schizophrenia

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00999505
• Other study ID #: 09-303
• Secondary ID: 09-303
• Status: Unknown status
• Phase: Phase 3
• First received: October 20, 2009
• Last updated: February 15, 2011
• Start date: May 2010
• Est. completion date: September 2011

Study information

• Verified date: February 2011
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Clarissa S Gama, MD, PhD
• Phone: 55-51-33598745
• Email: csgama[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Amantadine as add-on therapy to antipsychotics may improve schizophrenia positive, negative and cognitive symptoms.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 40
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Under antipsychotics with residual symptoms

Exclusion Criteria:

• Pregnancy

• Lactation

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Amantadine
Amantadine 200mg twice a day over 12 weeks
• Placebo
Placebo capsules twice a day over 12 weeks

Locations

Country	Name	City	State
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scores in Brief Psychiatric Rating Scale		Baseline, 4 weeks, 8 weeks, 12 weeks