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

NCT00693472 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2018-11-07

Study results available
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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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-15
Primary Completion
2008-12-12
Completion
2009-01-09

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00693472 on ClinicalTrials.gov