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.
Inclusion Criteria:
- Subjects or guardian must be willing to give written informed consent.
- Part 1 Only: Subjects with acute (not drug related) psychoses with a 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: Subjects 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 subjects who have developed akathisia as a result of
haloperidol at >=5 mg per day for the treatment of acute psychosis. The enrollment of
subjects receiving other neuroleptics is allowed only after consultation and agreement
by the sponsor.
- Subjects of either sex and of any race between the ages of 18 and 65 years,
inclusive.
- Subjects' clinical laboratory tests (CBC, blood chemistry, and urinalysis) must be
within normal limits or clinically acceptable to the investigator/sponsor. Subject's
liver function test results (ie, AST, ALT) must not be elevated above the normal
limits at Screening and on Day - 1/1.
- Subjects must be free of any clinically significant disease other than psychosis that
would interfere with the study evaluations.
- Screening ECG must be clinically acceptable to the investigator.
- Female of childbearing potential must:
- Have used a medically accepted method of contraception for 1 month (or abstained
from sexual intercourse) prior to the screening period. An acceptable method of
contraception includes one of the following:
- condom (male or female) ~ spermicide,
- diaphragm or cervical cap ~ spermicide and condom,
- stable oral/transdermal/injectable hormonal contraceptive regimen without
breakthrough uterine bleeding for 2 months prior to Screening visit and a
condom ~ spermicide,
- intrauterine device (inserted at least 2 months prior to Screening visit)
used spermicide.
Note: Vasectomy of the partner is not considered sufficient contraception and one of the 4
bulleted methods listed above must be used.
- Agree to use one of the accepted methods of contraception (listed above) during the
trial (including the screening period prior to receiving trial medication), and for 1
month after stopping the trial medication.
- Subjects enrolled in the placebo arm of Part 1 and who developed akathisia may be
eligible for Part 2 in the standard of care arm.
Exclusion Criteria:
- Subjects who have a positive screen for drugs with a high potential for abuse.
Subjects that screen positive for cannabis are permitted.
- Subjects who have previously received this compound.
- Subjects who are currently participating in another clinical study or have
participated in a clinical study within 30 days (excepted subjects enrolled in the
Part 1 of the P05145 study).
- Subjects who are part of the study staff personnel or family members of the study
staff personnel.
- Subjects with severe/uncontrolled hypertension will be excluded. Subjects with
hypertension well controlled on a stable dose of standard antihypertensive medication
(excluding beta-blockers) will be eligible.
- Subjects with history of coronary artery disease including MI, or cerebrovascular
disease (stroke, TIA), or peripheral arterial disease.
- Subjects with congestive heart failure or subjects with ECGs consistent with ischemic
heart disease, sick sinus syndrome or significant Q waves.
- Subjects who are found to be at immediate risk of suicide.
- Female subjects pregnant or nursing.
- Subjects treated by Clozapine will be excluded. A washout period of 6 months prior to
dosing will be acceptable for study entry.
