Assessing the Effects of Fanapt® on Social Cognition in Schizophrenia

NCT01929889 | Terminated Phase 4 Results

• 1 other identifier: CIL0522DUS03T
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

schizophrenia; schizoaffective disorder; iloperidone; Fanapt; social cognition; cognition

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline and twelve weeks

Study Arms (1)

Iloperidone

EXPERIMENTAL

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

Interventions

Iloperidone 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.

Also known as: Fanapt

Iloperidone

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (15)

• Barch DM, Smith E. The cognitive neuroscience of working memory: relevance to CNTRICS and schizophrenia. Biol Psychiatry. 2008 Jul 1;64(1):11-7. doi: 10.1016/j.biopsych.2008.03.003. Epub 2008 Apr 8.

  PMID: 18400207 BACKGROUND

• Bell M, Tsang HW, Greig TC, Bryson GJ. Neurocognition, social cognition, perceived social discomfort, and vocational outcomes in schizophrenia. Schizophr Bull. 2009 Jul;35(4):738-47. doi: 10.1093/schbul/sbm169. Epub 2008 Jan 31.

  PMID: 18245058 BACKGROUND

• Bell MD, Zito W, Greig T, Wexler BE. Neurocognitive enhancement therapy with vocational services: work outcomes at two-year follow-up. Schizophr Res. 2008 Oct;105(1-3):18-29. doi: 10.1016/j.schres.2008.06.026. Epub 2008 Aug 19.

  PMID: 18715755 BACKGROUND

• Bellack AS, Schooler NR, Marder SR, Kane JM, Brown CH, Yang Y. Do clozapine and risperidone affect social competence and problem solving? Am J Psychiatry. 2004 Feb;161(2):364-7. doi: 10.1176/appi.ajp.161.2.364.

  PMID: 14754789 BACKGROUND

• Brekke J, Kay DD, Lee KS, Green MF. Biosocial pathways to functional outcome in schizophrenia. Schizophr Res. 2005 Dec 15;80(2-3):213-25. doi: 10.1016/j.schres.2005.07.008. Epub 2005 Aug 30.

  PMID: 16137859 BACKGROUND

• Brune M. Emotion recognition, 'theory of mind,' and social behavior in schizophrenia. Psychiatry Res. 2005 Feb 28;133(2-3):135-47. doi: 10.1016/j.psychres.2004.10.007.

  PMID: 15740990 BACKGROUND

• Combs DR, Adams SD, Penn DL, Roberts D, Tiegreen J, Stem P. Social Cognition and Interaction Training (SCIT) for inpatients with schizophrenia spectrum disorders: preliminary findings. Schizophr Res. 2007 Mar;91(1-3):112-6. doi: 10.1016/j.schres.2006.12.010. Epub 2007 Feb 12.

  PMID: 17293083 BACKGROUND

• Derntl B, Finkelmeyer A, Toygar TK, Hulsmann A, Schneider F, Falkenberg DI, Habel U. Generalized deficit in all core components of empathy in schizophrenia. Schizophr Res. 2009 Mar;108(1-3):197-206. doi: 10.1016/j.schres.2008.11.009. Epub 2008 Dec 16.

  PMID: 19087898 BACKGROUND

• Glynn SM, Cohen AN, Dixon LB, Niv N. The potential impact of the recovery movement on family interventions for schizophrenia: opportunities and obstacles. Schizophr Bull. 2006 Jul;32(3):451-63. doi: 10.1093/schbul/sbj066. Epub 2006 Mar 8.

  PMID: 16525087 BACKGROUND

• Harvey PD, Penn D. Social cognition: the key factor predicting social outcome in people with schizophrenia? Psychiatry (Edgmont). 2010 Feb;7(2):41-4.

  PMID: 20376275 BACKGROUND

• Kane JM, Lauriello J, Laska E, Di Marino M, Wolfgang CD. Long-term efficacy and safety of iloperidone: results from 3 clinical trials for the treatment of schizophrenia. J Clin Psychopharmacol. 2008 Apr;28(2 Suppl 1):S29-35. doi: 10.1097/JCP.0b013e318169cca7.

  PMID: 18334910 BACKGROUND

• Penn DL, Roberts DL, Combs D, Sterne A. Best practices: The development of the Social Cognition and Interaction Training program for schizophrenia spectrum disorders. Psychiatr Serv. 2007 Apr;58(4):449-51. doi: 10.1176/ps.2007.58.4.449.

  PMID: 17412842 BACKGROUND

• Roberts DL, Penn DL, Labate D, Margolis SA, Sterne A. Transportability and feasibility of Social Cognition And Interaction Training (SCIT) in community settings. Behav Cogn Psychother. 2010 Jan;38(1):35-47. doi: 10.1017/S1352465809990464. Epub 2009 Oct 27.

  PMID: 19857363 BACKGROUND

• Wolwer W, Frommann N, Halfmann S, Piaszek A, Streit M, Gaebel W. Remediation of impairments in facial affect recognition in schizophrenia: efficacy and specificity of a new training program. Schizophr Res. 2005 Dec 15;80(2-3):295-303. doi: 10.1016/j.schres.2005.07.018. Epub 2005 Aug 24.

  PMID: 16125367 BACKGROUND

• Andreasen NC, Arndt S, Alliger R, Miller D, Flaum M. Symptoms of schizophrenia. Methods, meanings, and mechanisms. Arch Gen Psychiatry. 1995 May;52(5):341-51. doi: 10.1001/archpsyc.1995.03950170015003.

  PMID: 7726714 RESULT

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

iloperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Limitations and Caveats

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

Results Point of Contact

• Title: Dr. John Csernansky
• Organization: Northwestern University

jcsernan@nmff.org

312-503-9096

Study Officials

• John Csernansky, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lizzie Gilman Professor and Chairman, Department of Psychiatry and Behavioral Sciences

Study Record Dates

• First Submitted: August 19, 2013
• First Posted: August 28, 2013
• Study Start: April 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: October 1, 2014
• Last Updated: July 10, 2015
• Results First Posted: July 10, 2015

Record last verified: 2015-06

Locations

US (1)