Clinical trial NCT00693472 (phase 2, status: terminated)
Conditions: akathisia, drug-induced, antipsychotic agents, movement disorders
ICD codes: G47.61, G25.70, G25.9, H51.9, F98.4, G25.79, G25.89
Drugs: preladenant, placebo, anticholinergic agents or propanolol, haloperidol
SMILES: COCCOC1=CC=C(C=C1)N1CCN(CCN2N=CC3=C2N=C(N)N2N=C(N=C32)C2=CC=CO2)CC1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, O=C(O[C@H]1CN2CCC1CC2)N1CCC2=CC=CC=C2[C@@H]1C1=CC=CC=C1, OC1(CCN(CCCC(=O)C2=CC=C(F)C=C2)CC1)C1=CC=C(Cl)C=C1
Eligibility criteria:

        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 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) used with spermicide,

                    -  diaphragm or cervical cap used with spermicide and condom,

                    -  stable oral/transdermal/injectable hormonal contraceptive regimen without
                       breakthrough uterine bleeding for 2 months prior to Screening visit and a
                       condom used with spermicide,

                    -  intrauterine device (inserted at least 2 months prior to Screening visit)
                       used with 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.

          -  Participants 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:

          -  Participants who have a positive screen for drugs with a high potential for abuse.
             Participants that screen positive for cannabis are permitted.

          -  Participants who have previously received this compound.

          -  Participants who are currently participating in another clinical study or have
             participated in a clinical study within 30 days (except participants enrolled in the
             Part 1 of the P05145 study).

          -  Participants who are part of the study staff personnel or family members of the study
             staff personnel.

          -  Participants with severe/uncontrolled hypertension will be excluded. Participants with
             hypertension well controlled on a stable dose of standard antihypertensive medication
             (excluding beta-blockers) will be eligible.

          -  Participants with history of coronary artery disease including myocardial infarction
             (MI), or cerebrovascular disease (stroke, transient ischemic attack [TIA]), or
             peripheral arterial disease.

          -  Participants with congestive heart failure or participants with ECGs consistent with
             ischemic heart disease, sick sinus syndrome or significant Q waves.

          -  Participants who are found to be at immediate risk of suicide.

          -  Female participants pregnant or nursing.

          -  Participants treated by Clozapine will be excluded. A washout period of 6 months prior
             to dosing will be acceptable for study entry.