Assessing the Effects of Fanapt® on Social Cognition in Schizophrenia

• Status: Terminated
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University
• Collaborator: Novartis Pharmaceuticals
• Treatments: Iloperidone

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.