Switching to Iloperidone From Other Antipsychotics in Schizophrenia (i-FANS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01207414
First received: September 19, 2010
Last updated: February 4, 2013
Last verified: February 2013
Results First Received: December 18, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Schizophrenia
Intervention: Drug: iloperidone

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
500 participants taking antipsychotic drugs: 175 participants in the risperidone cohort, 155 participants in the olanzapine cohort and 170 participants in the aripiprazole cohort were randomized and received study drug in one of two iloperidone treatment arms: gradual switch or immediate switch. 1 randomized participant did not receive study drug.

Reporting Groups
  Description
Iloperidone Gradual Switch

Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week.

On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks.

Iloperidone Immediate Switch

Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately.

On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks.


Participant Flow:   Overall Study
    Iloperidone Gradual Switch     Iloperidone Immediate Switch  
STARTED     241 [1]   260  
Safety Population: Received Study Drug     240     260  
COMPLETED     168     178  
NOT COMPLETED     73     82  
Adverse Event                 25                 39  
Abnormal test procedure results                 0                 1  
Unsatisfactory therapeutic effect                 5                 4  
Patient withdrew consent                 14                 11  
Lost to Follow-up                 15                 17  
Administrative problems                 1                 1  
Protocol deviation                 12                 9  
Randomized in error                 1                 0  
[1] Includes 1 patient randomized in error.



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Iloperidone Gradual Switch

Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week.

On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks.

Iloperidone Immediate Switch

Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately.

On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks.

Total Total of all reporting groups

Baseline Measures
    Iloperidone Gradual Switch     Iloperidone Immediate Switch     Total  
Number of Participants  
[units: participants]
  240     260     500  
Age [1]
[units: years]
Mean ± Standard Deviation
  42.3  ± 10.98     44.2  ± 10.92     43.3  ± 10.98  
Gender  
[units: participants]
     
Female     70     95     165  
Male     170     165     335  
[1] Baseline Measures are based on the Safety Population that includes all randomized participants who received study drug.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Integrated Clinical Global Impression of Change (I-CGI-C) at Week 12   [ Time Frame: Week 12 ]

2.  Secondary:   Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) at Week 12   [ Time Frame: Baseline, Week 12 ]

3.  Secondary:   Number of Participants With Adverse Events, Serious Adverse Events or Death   [ Time Frame: 12 Weeks ]

4.  Secondary:   Change From Baseline in the Efficacy Clinical Global Impression of Severity (E-CGI-S) at Week 12   [ Time Frame: Baseline, Week 12 ]

5.  Secondary:   Change From Baseline in the Safety and Tolerability Clinical Global Impression of Severity (ST-CGI-S) at Week 12   [ Time Frame: Baseline, Week 12 ]

6.  Secondary:   Change From Baseline in Integrated Clinical Global Impression of Severity (I-CGI-S) at Week 12   [ Time Frame: Baseline, Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300


No publications provided


Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01207414     History of Changes
Other Study ID Numbers: CILO522DUS01
Study First Received: September 19, 2010
Results First Received: December 18, 2012
Last Updated: February 4, 2013
Health Authority: United States: Food and Drug Administration