F17464 in Acute Schizophrenia Trial (FAST)

Pierre Fabre

Status and phase

Completed

Phase 2

Conditions

Schizophrenia

Treatments

Drug: F17464

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02151656

F17464 GE 2 01

2013-005451-32 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

158 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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