Clinical trial NCT00403546 (phase 3, status: completed)
Conditions: schizophrenia
ICD codes: F20.0, F20.1, F20.2, F20.3, F20.5, F20.89, F20.9
Drugs: ziprasidone 80-160 mg/d, placebo, ziprasidone 160 mg/d
SMILES: ClC1=C(CCN2CCN(CC2)C2=NSC3=CC=CC=C23)C=C2CC(=O)NC2=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, ClC1=C(CCN2CCN(CC2)C2=NSC3=CC=CC=C23)C=C2CC(=O)NC2=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Schizophrenia or Schizoaffective disorder, any subtype

          -  Age 18-65 years

          -  Treated with ziprasidone at a dose of 160 mg/d for at least 3 weeks with adequate
             compliance

          -  Concomitant standing or other medications as needed (except other antipsychotics and
             those noted as contraindicated in the ziprasidone package insert) are permitted during
             all treatment phases if they were present at a stable dose for at least 6 weeks prior
             to the start of initial ziprasidone treatment

          -  A score of 4 (moderate) or greater on any of the 7 items of the PANSS Positive Symptom
             Subscale

          -  Clinical judgment by the investigator that doses higher than 160 mg/day are warranted
             due to suboptimal clinical outcome despite adequate treatment at that dose

          -  Participant is judged capable of understanding all relevant risks and potential
             benefits of the study and has signed informed consent

          -  Comorbid axis 1 conditions (including anxiety disorders, eating disorders, impulse
             control disorders) are permitted if they have been stable and have not been a primary
             focus of treatment over the previous 6 months

        Exclusion Criteria:

          -  Past or current intolerance of ziprasidone side effects

          -  Presence of significant cardiac disease, including uncompensated congestive heart
             failure, myocardial infarction within the past 6 months or known history of congenital
             long QT interval syndrome

          -  Corrected QT interval (QTc) greater than or equal to 500 milliseconds (msec)

          -  Serum potassium and magnesium concentrations outside of normal limits.

          -  Currently taking any medications which may affect cardiac conduction

          -  Presence of any unstable or untreated medical disorder

          -  Any history of seizures or seizure disorder other than febrile seizures of childhood

          -  History of positive hepatitis B surface antigen

          -  Human immunodeficiency virus (HIV) positive or has diagnosis of acquired immune
             deficiency syndrome (AIDS)

          -  Any abnormal laboratory test that is judged to be clinically significant by the
             investigator

          -  History of neuroleptic malignant syndrome (NMS), hypersensitivity or allergic response
             to antipsychotic therapy, including ziprasidone

          -  History of clozapine treatment for refractory psychotic symptoms

          -  Alcohol or substance dependence within the past 12 months or abuse within the past 3
             months. Any subject with positive urine toxicology or alcohol use that is considered
             abnormal at baseline.

          -  Clinically significant suicidal or homicidal behavior or attempts within past 6 months

          -  Any subject judged by the investigator to present a danger to self or others.

          -  Women of childbearing potential who are not using adequate contraception (oral
             contraceptives, barrier methods or who are clearly abstinent)

          -  Pregnancy or breast-feeding

          -  Any subject who is judged by the investigator to be unable or unlikely to comply with
             all study requirements, including adherence with prescribed medication regimen