Trial Outcomes & Findings for Assessing the Effects of Fanapt® on Social Cognition in Schizophrenia (NCT NCT01929889)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

19 participants

Primary outcome timeframe

baseline and twelve weeks

Results posted on

2015-07-10

Participant Flow

The study target enrollment goal was 20 completed subjects.

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.

Participant milestones

Participant milestones
Measure	A Single Arm, Open Label, Exploratory Study 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.
Overall Study STARTED	8
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessing the Effects of Fanapt® on Social Cognition in Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Iloperidone n=8 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	28 years STANDARD_DEVIATION 10.42 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Iloperidone n=3 Participants 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.
Change in Social Cognition at 12 Weeks Facial Affect Perception Test	0 units on a scale Standard Deviation 3.742
Change in Social Cognition at 12 Weeks Cognitive Empathy Test	-3.333 units on a scale Standard Deviation 6.807

Adverse Events

Iloperidone

Serious events: 3 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Iloperidone n=8 participants at risk 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.
Psychiatric disorders Hospitalization	37.5% 3/8 • Number of events 3 • Adverse events were systematically collected throughout the study.

Other adverse events

Other adverse events
Measure	Iloperidone n=8 participants at risk 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.
Gastrointestinal disorders Abdominal pain	25.0% 2/8 • Number of events 2 • Adverse events were systematically collected throughout the study.

Additional Information

Dr. John Csernansky

Northwestern University

Phone: 312-503-9096

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place