Clinical Trial: Study of Preladenant for the Treatment of Neuroleptic Induced Akathisia (Study P05145AM1)(COMPLETE)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Efficacy of SCH 420814 to Reduce the Frequency or Severity of Neuroleptic Induced Akathisia
Brief Summary: This study is designed to evaluate the effectiveness of preladenant in the prevention (Part 1) or treatment (Part 2) of antipsychotic induced akathisia in subjects with acute psychosis using the Barnes Akathisia Scale.
Detailed Summary:
Sponsor: Merck Sharp & Dohme Corp.
Current Primary Outcome: Part 1: Incidence of akathisia; Part 2: Incidence of treatment failure [ Time Frame: Day 13 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Part 1 only: number of subjects that have a prevention failure (defined as the onset of akathisia) [ Time Frame: Day 13 ]
- Part 1: Global Clinical Impression, positive and negative symptom scale for schizophrenia (PANSS) Part 2: Global Clinical Impression, positive and negative symptom scale for schizophrenia (PANSS) [ Time Frame: Daily ]
Original Secondary Outcome: Same as current
Information By: Merck Sharp & Dohme Corp.
Dates:
Date Received: May 27, 2008
Date Started: August 2007
Date Completion:
Last Updated: November 2, 2015
Last Verified: November 2015
