Assessing the Effects of Fanapt® on Social Cognition in Schizophrenia



Status:Terminated
Conditions:Schizophrenia, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 55
Updated:4/21/2016
Start Date:April 2012
End Date:October 2014

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An Exploratory Study to Assess the Effects of Fanapt® on Social Cognitive Performance

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.

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.

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.
We found this trial at
1
site
303 East Superior Street
Chicago, Illinois 60611
?
mi
from
Chicago, IL
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