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Assessing the Effects of Fanapt® on Social Cognition in Schizophrenia

Sponsor
Northwestern University (Other)
Overall Status
Terminated
CT.gov ID
NCT01929889
Collaborator
Novartis Pharmaceuticals (Industry)
19
Enrollment
1
Location
1
Arm
30
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Exploratory Study to Assess the Effects of Fanapt® on Social Cognitive Performance
Study Start Date :
Apr 1, 2012
Actual Primary Completion Date :
Feb 1, 2014
Actual Study Completion Date :
Oct 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: 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.
Other Names:
  • Fanapt

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in Social Cognition at 12 Weeks [baseline and twelve 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Northwestern University Chicago Illinois United States 60611

    Sponsors and Collaborators

    • Northwestern University
    • Novartis Pharmaceuticals

    Investigators

    • Principal Investigator: John Csernansky, MD, Northwestern University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    John Csernansky, Lizzie Gilman Professor and Chairman, Department of Psychiatry and Behavioral Sciences, Northwestern University
    ClinicalTrials.gov Identifier:
    NCT01929889
    Other Study ID Numbers:
    • CIL0522DUS03T
    First Posted:
    Aug 28, 2013
    Last Update Posted:
    Jul 10, 2015
    Last Verified:
    Jun 1, 2015
    Keywords provided by John Csernansky, Lizzie Gilman Professor and Chairman, Department of Psychiatry and Behavioral Sciences, Northwestern University
    schizophrenia
    schizoaffective disorder
    iloperidone
    Fanapt
    social cognition
    cognition
    Additional relevant MeSH terms:
    Schizophrenia
    Psychotic Disorders
    Iloperidone

    Study Results

    Participant Flow

    Recruitment Details The study target enrollment goal was 20 completed subjects.
    Pre-assignment Detail 19 subjects were consented and completed the study screening visit.11 subjects did not start on the treatment after signing the consent form. The most common reason for early termination was disagreement between the subjects' self-reported diagnosis and the diagnosis obtained by the research psychiatrist.
    Arm/Group Title A Single Arm, Open Label, Exploratory Study
    Arm/Group Description This is a single arm, open label, exploratory study to examine effects of Fanapt (iloperadone) on social cognition. 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.
    Period Title: Overall Study
    STARTED 8
    COMPLETED 3
    NOT COMPLETED 5

    Baseline Characteristics

    Arm/Group Title Iloperidone
    Arm/Group 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.
    Overall Participants 8
    Age (Count of Participants)
    <=18 years
    0
    0%
    Between 18 and 65 years
    8
    100%
    >=65 years
    0
    0%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    28
    (10.42)
    Sex: Female, Male (Count of Participants)
    Female
    1
    12.5%
    Male
    7
    87.5%
    Region of Enrollment (participants) [Number]
    United States
    8
    100%

    Outcome Measures

    1. Primary Outcome
    Title Change in Social Cognition at 12 Weeks
    Description 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.
    Time Frame baseline and twelve weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Iloperidone
    Arm/Group 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.
    Measure Participants 3
    Facial Affect Perception Test
    0
    (3.742)
    Cognitive Empathy Test
    -3.333
    (6.807)

    Adverse Events

    Time Frame Adverse events were systematically collected throughout the study.
    Adverse Event Reporting Description
    Arm/Group Title Iloperidone
    Arm/Group 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.
    All Cause Mortality
    Iloperidone
    Affected / at Risk (%) # Events
    Total / (NaN)
    Serious Adverse Events
    Iloperidone
    Affected / at Risk (%) # Events
    Total 3/8 (37.5%)
    Psychiatric disorders
    Hospitalization 3/8 (37.5%) 3
    Other (Not Including Serious) Adverse Events
    Iloperidone
    Affected / at Risk (%) # Events
    Total 2/8 (25%)
    Gastrointestinal disorders
    Abdominal pain 2/8 (25%) 2

    Limitations/Caveats

    The most common reason for early termination was disagreement between the subjects' self-reported diagnosis and the diagnosis obtained by the research psychiatrist.

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. John Csernansky
    Organization Northwestern University
    Phone 312-503-9096
    Email jcsernan@nmff.org
    Responsible Party:
    John Csernansky, Lizzie Gilman Professor and Chairman, Department of Psychiatry and Behavioral Sciences, Northwestern University
    ClinicalTrials.gov Identifier:
    NCT01929889
    Other Study ID Numbers:
    • CIL0522DUS03T
    First Posted:
    Aug 28, 2013
    Last Update Posted:
    Jul 10, 2015
    Last Verified:
    Jun 1, 2015