September 29, 2016
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Efficacy of ITI-007 for schizophrenia did not surpass placebo

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Results from a second phase 3 clinical trial indicated ITI-007, an oral investigational treatment for schizophrenia, was not superior to placebo, while the active control risperidone was superior, according to a press release from Intra-Cellular Therapies.

“It is not uncommon in the field of psychiatry for studies to be challenged by high placebo response and there has been great variability in the effects observed from one study to the next,” Christoph Correll, MD, professor of psychiatry at Hofstra Northwell School of Medicine, said in the release. “Taken together, the ITI-007 schizophrenia program supports ITI-007 as a unique medication with an unprecedented safety and tolerability profile.”

Christoph U. Correll, MD
Christoph Correll

Two large-scale schizophrenia studies demonstrated the efficacy of ITI-007, including one that showed ITI-007 and risperidone had similar efficacy.

“In light of the results to date, I believe that ITI-007 represents a unique investigational medication which has the potential to advance the treatment of patients suffering from schizophrenia,” Correll said.

Researchers conducted a randomized, double-blind, fixed-dose, placebo- and active-controlled inpatient clinical trial among 696 individuals with schizophrenia and an acute exacerbation of psychosis across 13 sites in the United States. Study participants were randomly assigned to receive 60 mg or 20 mg of ITI-007, 4 mg of risperidone as an active control, or placebo once daily in the morning for 6 weeks. Dose titration from 2 mg to 4 mg was required for risperidone and was not required for ITI-007.

Change in Positive and Negative Syndrome Scale (PANSS) scores were –14.6 points among participants who received 60 mg of ITI-007, –15 points among those who received 20 mg of ITI-007, compared with –15.1 in the placebo group.

Participants who received risperidone exhibited a change in PANSS scores of –20.5.

Magnitude of change PANSS scores was similar for 60 mg of ITI-007 across all three studies and was comparable to the active control, risperidone, according to researchers.

Researchers noted an unusually high placebo response in this particular study.

“Based on the strength of the clinical data generated in this program to date, including two positive studies, supportive evidence from Study 302 and a consistent, well-tolerated and placebo-like safety profile across all studies, we continue to believe ITI-007 will be an important treatment for patients suffering from schizophrenia,” Sharon Mates, PhD, chairman and CEO of Intra-Cellular Therapies, said in the release. “We remain committed to the development of ITI-007 for the treatment of schizophrenia, bipolar depression, agitation associated with dementia, including Alzheimer's disease and other neuropsychiatric indications.”