Assessing the Effects of Fanapt® on Social Cognition in Schizophrenia

NCT ID: NCT01929889

Last Updated: 2015-07-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2014-10-31

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Iloperidone

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.

Group Type: EXPERIMENTAL

Iloperidone

Intervention Type: DRUG

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.

Interventions

Iloperidone

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 Type: DRUG

Other Intervention Names

Fanapt

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

John Csernansky

Lizzie Gilman Professor and Chairman, Department of Psychiatry and Behavioral Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John Csernansky, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University

Chicago, Illinois, United States

Countries

United States

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Other Identifiers

CIL0522DUS03T

Identifier Type: -

Identifier Source: org_study_id