Assessing the Effects of Fanapt® on Social Cognition in Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: Iloperidone
Intervention description: Patients in this study will be treated with Fanapt® (iloperidone). They will begin a standardized up-titration starting with a dose of 2 mg daily. Dose increases will continue until the subject has achieved clinical stability, has achieved the maximum dose of 24 mg/day, or until 8 weeks have elapsed. Once clinical stability has been achieved, the patient will continue into the treatment phase. If clinical stability is not achieved after 8 weeks, the patient will be excluded from the study.
Intervention MeSH terms: Iloperidone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: schizophrenia; schizoaffective disorder; iloperidone; Fanapt; social cognition; cognition

Summary:

      The study looks at whether treatment with iloperidone (Fanapt) is associated with
      improvements in social cognition in individuals who have been recently diagnosed with
      schizophrenia or schizoaffective disorder. Social cognition (the ability to understand your
      feelings and the feelings of others) is closely related to functional outcomes, including
      communication, empathy, and emotional recognition.
    

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.