Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Donald C. Goff, MD
With
Pfizer
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
