Status:
TERMINATED
Study of Amantadine for Risperidone Consta or Paliperidone Treated Patients to Decrease Prolactin Elevation
Lead Sponsor:
David C. Henderson, MD
Collaborating Sponsors:
Ortho-McNeil Janssen Scientific Affairs, LLC
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to show that amantadine might help to reduce the side effect of the medications which are prescribed to treat schizophrenia or schizoaffective disorder. High level of horm...
Detailed Description
Trial Description: A double-blind, placebo-controlled, prospective, randomized trial to evaluate the effects of two doses of amantadine or placebo in the management of antipsychotic-induced hyperprola...
Eligibility Criteria
Inclusion
- Male or female
- Age 18-65 years
- Diagnosis of schizophrenia, schizoaffective disorder, any subtype or schizophreniform disorder
- Well established compliance with out-patient medications including paliperidone ER or risperidone Consta for 3 months
Exclusion
- Current substance or alcohol abuse
- Significant medical illness
- Women who are pregnant, breastfeeding, or who are unwilling or unable to use an effective form of birth control during the entire study
- Subjects treated with more than one antipsychotic drug
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00975611
Start Date
October 1 2009
End Date
January 1 2012
Last Update
June 10 2013
Active Locations (1)
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1
Freedom Trail Clinic
Boston, Massachusetts, United States, 02459