Clinical trial NCT01929889
Conditions: Schizophrenia Schizoaffective Disorder
Keywords: schizophrenia schizoaffective disorder iloperidone Fanapt social cognition cognition
Sponsor: Northwestern University
Start date: 2012-04-01; Completion date: 2014-10-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief 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.

Detailed description:
Schizophrenia is a disabling disease that affects about 1% of the population and is one of the leading causes of psychiatric disability. Striking early in life, schizophrenia interferes with work, relationships, and independence. Despite the billions of dollars spent annually in the direct and indirect costs of this disease, there are few treatment options that restore functionality. Lately, cognition has emerged as a target for interventions, since a patient's cognitive status is one of the most reliable predictors of functional outcome, and yet treatments for improving cognition have delivered only modest results. This study will attempt to evaluate the efficacy of Fanapt® (iloperidone) on social cognition, which consists of factors such as empathy, social perception, and emotional recognition, and may be more meaningfully tied to functional outcome than cognition in general.

This study will assess social cognition in people with schizophrenia or schizoaffective disorder who have newly begun taking Fanapt® (iloperidone), a new antipsychotic with mixed dopamine and serotonin antagonism. Standard measures of psychopathology and social cognition will be collected at baseline and then again at 12 weeks after becoming stable on the medication, by raters who are blind to the length of a subject's participation in the study. We predict that social cognition will improve with treatment with Fanapt®. This study has relatively few risks, including no risks beyond exposure to the study medication and the collection of safety data and psychometric data. The potential benefits outweigh the risks, with the main benefit being an ability to describe an improvement in cognitive performance that is believed to relate directly to real-world functional outcome.

Arms: arm 1: 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.
Interventions: intervention 1: Iloperidone
Intervention descriptions: intervention 1: 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.

Protocol documents: