The purpose of this study is to determine whether Iloperidone is effective in the prevention of relapse in patients with schizophrenia
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
635
Over-encapsulated iloperidone tablets were administered orally using a bid schedule; the strengths used include 1, 2, 4, 6, 8, 10, and 12 mg.
Matching placebo capsules were administered orally using a bid schedule during the double-blind period.
Time to Relapse or Impending Relapse
Relapse or impending relapse was defined as any of the following: hospitalization due to worsening of schizophrenia; increase (worsening) of the PANSS total score of greater than or equal to 30% from randomization, PANSS total score confirmed at a second visit conducted within 1-7 days; clinically significant emergent or worsening suicidal, homicidal, or aggressive behavior; a CGI-Improvement (CGI-I) score of 6 (much worse) or 7 (very much worse) after randomization; a dose increase in study medication or a need for additional open-label antipsychotic treatment.
Time frame: Up to 26 weeks post-randomization
PANSS Total Score, Change From Baseline to Last Visit
The 30-item Positive and Negative Syndrome Scale (PANSS) was developed to assess the severity of symptoms of schizophrenia. The PANSS items are divided into positive, negative, and general psychopathology factors. All items were rated on a scale of 1 (absent) to 7 (extremely severe). The PANSS total score (or rating) is the sum of all 30 PANSS items taken together (the sum of its 3 subscales), with a maximum score of 210. Change from baseline is calculated as post value minus baseline value. A negative change indicates improvement.
Time frame: Up to 26 weeks post-randomization
CGI-S, Last Visit
The 7-item Clinical Global Impression of Severity (CGI-S) scale was developed to assess the overall, absolute degree of illness at any point in time. A rating of 1 is equivalent to "normal, not at all ill," and a rating of 7 is equivalent to "among the most extremely ill patients."
Time frame: Up to 26 weeks post-randomization
SDS Total Score, Change From Baseline to Last Visit
The Sheehan Disability Scale (SDS) a self-reported measure that was developed to assess functional impairment in 3 inter-related domains (i.e., work/school, social, and family life). It is a 10-point visual analog scale with 0 being not impaired at all and 10 extremely impaired. Change from baseline is calculated as post value minus baseline value. A negative change indicates improvement.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Vanda Investigative Site
Anaheim, California, United States
Vanda Investigative Site
Bellflower, California, United States
Vanda Investigative Site
Costa Mesa, California, United States
Vanda Investigative Site
Escondido, California, United States
Vanda Investigative Site
La Habra, California, United States
Vanda Investigative Site
Oceanside, California, United States
Vanda Investigative Site
Orange, California, United States
Vanda Investigative Site
Pico Rivera, California, United States
Vanda Investigative Site
Riverside, California, United States
Vanda Investigative Site
San Diego, California, United States
...and 53 more locations
Time frame: Up to 26 weeks post-randomization