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Assessing the Effects of Fanapt® on Social Cognition in Schizophrenia

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Iloperidone

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, schizoaffective disorder, iloperidone, Fanapt, social cognition, cognition

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Northwestern University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Iloperidone

Arm 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.

Outcomes

Primary Outcome Measures

Change in Social Cognition at 12 Weeks

Facial Affect Perception Test that assesses the ability to accurately recognize facially expressed emotions as published by Smith et al 2014; Derntl et al., 2009. This scale ranges from 0-100 percent with a total of 30 trials. We examined the percent correct as the total number of correct responses divided by the total number of completed trials. There were no subscales. 100% accurate is the best outcome and 0% accurate is the worst outcome. Cognitive Empathy Test that assesses the ability to accurately determine the emotional expression of another person as depicted in a static image of a social interaction as published by Smith et al 2014; Derntl et al., 2009. This scale ranges from 0-100 percent with a total of 60 trials. We examined the percent correct as the total number of correct responses divided by the total number of completed trials. There were no subscales. 100% accurate is the best outcome and 0% accurate is the worst outcome.

Secondary Outcome Measures

Full Information

NCT ID

NCT01929889

First Posted

August 19, 2013

Last Updated

July 6, 2015

Sponsor

Northwestern University

Collaborators

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01929889

Brief Title

Assessing the Effects of Fanapt® on Social Cognition in Schizophrenia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Terminated

Why Stopped

Low recruitment

Study Start Date

April 2012 (undefined)

Primary Completion Date

February 2014 (Actual)

Study Completion Date

October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

Collaborators

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia, Schizoaffective Disorder

Keywords

schizophrenia, schizoaffective disorder, iloperidone, Fanapt, social cognition, cognition

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Iloperidone

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Iloperidone

Other Intervention Name(s)

Fanapt

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.

Primary Outcome Measure Information:

Title

Change in Social Cognition at 12 Weeks

Description

Time Frame

baseline and twelve weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John Csernansky, MD

Organizational Affiliation

Northwestern University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northwestern University

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

18400207

Citation

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Citation

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Citation

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Citation

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result

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Assessing the Effects of Fanapt® on Social Cognition in Schizophrenia

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