Study of Preladenant for the Treatment of Neuroleptic Induced Akathisia (Study P05145) (NCT00693472) | Clinical Trial Compass
TerminatedPhase 2
Study of Preladenant for the Treatment of Neuroleptic Induced Akathisia (Study P05145)
46 participantsStarted 2007-08-15
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Participants or guardian must be willing to give written informed consent.
* Part 1 Only: Participants with acute (not drug related) psychoses with a Positive and Negative Symptom Scale for Schizophrenia (PANSS) score of at least 60: schizophrenia, schizo-affective, schizo-manic, and acute mania with a history of previous treatment with neuroleptics.
* Part 1 Only: Participants initiating haloperidol for the treatment of an acute psychotic episode at a dose of at least 7.5 mg per day.
* Part 2 Only: Inpatient participants who have developed akathisia as a result of haloperidol at \>=5 mg per day for the treatment of acute psychosis. The enrollment of participants receiving other neuroleptics is allowed only after consultation and agreement by the sponsor.
* Participants of either sex and of any race between the ages of 18 and 65 years, inclusive.
* Participant's clinical laboratory tests (complete blood count \[CBC\], blood chemistry, and urinalysis) must be within normal limits or clinically acceptable to the investigator/sponsor. Participant's liver function test results (ie, aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\]) must not be elevated above the normal limits at Screening and on Day -1/1.
* Participants must be free of any clinically significant disease other than psychosis that would interfere with the study evaluations.
* Screening electrocardiogram (ECG) must be clinically acceptable to the investigator.
* Female of ch…
What they're measuring
1
Part 1: Number of Participants With Akathisia
Timeframe: Up to 13 days
2
Part 2: Number of Participants Who Were Treatment Failures