f17464 in acute schizophrenia trial

Conditions: Schizophrenia

Summary: the purpose of this study is to evaluate the potential efficacy of oral f17464 in comparison to placebo over 6 weeks in patients with acute exacerbation of schizophrenia. study design: double-blind, randomized, placebo-controlled, parallel-groups, fixed-dose design, multicentre study.


Eligibility criteria:
inclusion criteria: demographic and other characteristics * male or female, 18-64 years of age inclusive * primary diagnosis of schizophrenia undergoing an acute exacerbation with prominent "active phase" symptoms, as described by the diagnostic and statistical manual of mental disorders, 4th edition - text revision (dsm iv-tr) using the mini 6.0 (mini-international neuropsychiatric interview) for schizophrenia and psychotic disorders related to dsm iv-tr * well-documented diagnosis of schizophrenia for a minimum of 1 year before the screening visit * since the diagnosis of schizophrenia, the average number of hospitalisations should be no higher than 2 per year (the minimum duration of hospitalization should be more than 4 days) * during the year before visit 1, maximum 3 acute psychotic episodes that required hospitalization or change of antipsychotic medication or other therapeutic intervention * adequate clinical response to well-conducted treatment courses during previous acute episodes. a well conducted treatment course is defined as an antipsychotic treatment with the usual doses for at least 4 weeks current acute episode * structured clinical interview for the positive and negative syndrome scale (sci-panss) with a panss total score ≥ 70 to \< 120 (at visit 1 and 2) * rating of at least 4 (moderate) on at least 2 of the following 4 panss positive symptoms: delusions, hallucinatory behaviour, conceptual disorganization, suspiciousness/persecution * clinical global impression of severity (cgi-s) score ≥ 4 (moderate or severe) * antipsychotic initiated for this acute episode and/or ongoing chronic antipsychotic treatment, with a maximum of 2 antipsychotics in total needed to be changed (due to inefficacy or safety reasons) * hospitalization and/ or treatment for the current psychotic episode for less than 2 weeks prior to visit 1 * no significant improvement of panss total score between enrolment (visit 1) and inclusion (visit 2) corresponding to a score improvement \< 20% on positive symptoms subscale exclusion criteria: related to the pathology * patients in their first acute episode of psychosis * current schizophrenic episode with predominant negative symptoms * patient " known to be refractory " defined as lack of significant improvement (no significant relief of symptoms, and no period of good function) despite adequate courses with at least 3 different antipsychotics medication cycles of an adequate duration (at least 4 weeks) and at adequate dosage during the previous 5 years; * schizoaffective disorder, schizophreniform disorder and other psychotic disorders; * bipolar i and ii disorder * pervasive developmental disorder, mental retardation, delirium, dementia, memory impairment and other cognitive disorders that would compromise a reliable assessment according to the investigator's opinion * known or suspected borderline or antisocial personality disorder or other dsm iv axis ii disorder of sufficient severity to interfere with participation in this study * history of tardive dyskinesia or chronic extra-pyramidal symptoms (eps), serotonin syndrome or neuroleptic malignant syndrome * major depressive disorder which requires a pharmacological treatment * at imminent risk of injuring him/herself or others or causing significant damage to property, as judged by the investigator * suicidal risk based on the columbia-suicide severity rating scale (c-ssrs) * any suicidal behavior in the past year * suicidal ideation of type 4 or 5 in the past month related to treatments * structured psychotherapy (e.g. cognitive behavioural therapy) started within 6 weeks before visit 1 * electroconvulsive therapy within 3 months before visit 1 * previous lack of response to electroconvulsive therapy * treatment ongoing with a depot neuroleptic (even if less than 1 cycle in duration before visit 1) * patient having previous treatment course with clozapine within the 4 months prior to visit 1 * requirement of concomitant treatment with any of the prohibited medications * history of intolerance or hypersensitivity to other drugs of the same chemical class as f17464 or to rescue medications or any history of severe drug allergy or hypersensitivity

Keywords: schizophrenia mental disorders antipsychotic drugs