Clinical trial NCT01499563: Study of a Novel Antipsychotic ITI-007 in Schizophrenia
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Antipsychotic Efficacy of ITI-007 in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Lead sponsor: Intra-Cellular Therapies, Inc.
Sponsor class: INDUSTRY
First posted: 2011-12-26
Enrollment: 335
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate whether ITI-007 is effective in reducing symptoms associated with schizophrenia in patients who are having an acute worsening of their psychosis. Patients will be randomly assigned to receive one of two doses of ITI-007, placebo, or a positive control. The primary goal will be to assess the effects of ITI-007 on psychosis. The safety of ITI-007 will also be assessed.

Detailed description: The study will be conducted as a randomized, double-blind, placebo-controlled, multi-center study in patients diagnosed with schizophrenia and an acute exacerbation of psychosis. The efficacy and safety of two dose levels of ITI-007 administered daily for 28 days will be evaluated as compared to placebo; risperidone has been included as a positive control.

Upon completion of the inpatient 28-day Study Treatment Period, patients will be started on standard antipsychotic medication and will be stabilized over a 5-day period before discharge from the study clinic. Patients will be seen for a final outpatient safety evaluation at the End-of-Study visit approximately 2 weeks after discharge.

Eligibility criteria: Inclusion Criteria:

* Patient's age is 18-55
* Patient has current diagnosis of schizophrenia and is experiencing an acute exacerbation of psychosis
* Patient has a history of at least three months exposure to one or more antipsychotic therapy(ies) and a prior response to antipsychotic therapy within the previous five years

Exclusion Criteria:

* Any female patient who is pregnant or breast-feeding
* Any patient presenting with concurrent dementia, delirium, mental retardation, epilepsy, drug-induced psychosis, or history of significant brain trauma
* Any patient presenting with schizoaffective disorder, bipolar disorder, acute mania, or major depression with psychotic features
* Any patient considered to be an imminent danger to themselves or others
* Any patient with hematological, renal, hepatic, endocrinological, neurological, or cardiovascular disease or substance abuse as defined by protocol
* Any patient judged by the Investigator to be inappropriate for the study

Primary outcomes:
measure: Positive and Negative Syndrome Scale (PANSS) total score
timeFrame: Change from baseline to Day 28
Secondary outcomes:
measure: Positive and Negative Syndrome Scale (PANSS) total score
timeFrame: Change from baseline to Day 8, 15, 22
Other outcomes:
Locations:
city: Long Beach
country: United States
state: California
Study officials:
affiliation: Intra-Cellular Therapies
name: Kimberly E Vanover, PhD
role: STUDY_DIRECTOR
References:
citation: Lieberman JA, Davis RE, Correll CU, Goff DC, Kane JM, Tamminga CA, Mates S, Vanover KE. ITI-007 for the Treatment of Schizophrenia: A 4-Week Randomized, Double-Blind, Controlled Trial. Biol Psychiatry. 2016 Jun 15;79(12):952-61. doi: 10.1016/j.biopsych.2015.08.026. Epub 2015 Aug 31.