NCT00693472

Study of Preladenant for the Treatment of Neuroleptic Induced Akathisia (Study P05145)

Efficacy of SCH 420814 to Reduce the Frequency or Severity of Neuroleptic Induced Akathisia

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 participants with acute psychosis using the Barnes Akathisia Scale.

Conditions

• Akathisia, Drug-Induced
• Antipsychotic Agents
• Movement Disorders

Interventions

Type	Name	Description
DRUG	Preladenant	Preladenant, one 25 mg capsule, administered orally every 12 hours
DRUG	Placebo	Matching placebo capsule administered orally every 12 hours
DRUG	Anticholinergic agents or propanolol	Part 1 (as rescue therapy only): participants who develop akathisias may be treated with either anticholinergic agents or propranolol as a rescue medication at the discretion of the treating physician. Individual anticholinergic agents were not pre-specified per protocol. Part 2 (standard of care): anticholinergic agents or propanolol at a dose determined by the investigator according to the local standard of care. Individual anticholinergic agents were not pre-specified per protocol.
DRUG	Haloperidol	Participants continued pre-study haloperidol, admistered orally, at a dose of at least 7.5 mg/day

Timeline

• Start date: 2007-08-15
• Primary completion: 2008-12-12
• Completion: 2009-01-09
• First posted: 2008-06-09
• Last updated: 2018-11-07
• Results posted: 2017-05-24