Intervention: Iloperidone
Trial phase: Phase 4
ATC code: N05AX14
SMILES: COc1cc(C(C)=O)ccc1OCCCN1CCC(c2noc3cc(F)ccc23)CC1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Patients currently taking an antipsychotic medication other than Fanapt® will switch from their current medicine to Fanapt® in a cross-titration at a rate that is determined by the study physician. Treatment with iloperidone will be initiated and dosage will increase until the subject has achieved clinical stability, or has achieved the maximum dose, or 8 weeks have elapsed. Subjects who do not achieve clinical stability (as defined in the inclusion criteria) for the final 2 weeks in this 8-week period at the maximum dose of iloperidone will be discontinued from the study. If patients achieve stabilization, the lowest effective dose will be maintained. Subjects who have achieved clinical stability will then enter the 12-week treatment phase of the study.
Eligibility criteria:
Inclusion Criteria:

Ability to give written informed consent
Male and female patients 18-55 years old
DSM-IV-TR diagnosis of schizophrenia or schizoaffective disorder.
Less than 5-year treatment history for schizophrenia or schizoaffective disorder.
Clinically stable for the last 2 weeks of the Fanapt® screening and stabilization phases.
Sufficiently stable overall health.
Women who can become pregnant must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study

Exclusion Criteria:

People unable to give informed consent
Baseline performance of 95% or higher on the cognitive empathy assessment
Pregnant and lactating women
A positive test for Hepatitis C antibody with concurrent evidence of impaired hepatic function
Subjects with a history of medical conditions which would pose a risk to the patient if they were to participate in the study or that might confound the results of the study
Known hypersensitivity to Fanapt® or any components in its formulation
History of organic brain disorder
History of autism, pervasive developmental disability, mental retardation, or other cognitive disorder that could potentially confound cognitive testing
History of any medical condition that would confound the presentation or treatment of schizophrenia or schizoaffective disorder, or significantly increase the risk associated with the proposed treatment protocol
History of QTc prolongation, cardiac arrhythmias, or family history of sudden cardiac death
Patients taking strong inhibitors of CYP2D6 (fluoxetine, paroxetine, etc.) or CYP3A4 (ketoconazole, itraconazole, cimetidine, cyclosporine, etc.) or other medications that interact significantly with iloperidone
Patients who have met DSM-IV-TR criteria for current alcohol or substance dependence within the last six months or DSM-IV-TR criteria for alcohol or substance abuse within the last month
Patients regularly taking any medication that is known to interfere with performance on cognitive and social cognitive tasks, such as anticholinergics and benzodiazepines. Occasional benzodiazepine use may be permitted if subject can safely refrain from use for at least 24 hours prior to study visits.