F17464 in Acute Schizophrenia Trial

• Register: ClinicalTrials.gov
• Last refreshed on: 9 January 2017
• Main ID: NCT02151656
• Date of registration: 28/05/2014
• Prospective Registration: Yes
• Primary sponsor: Pierre Fabre Medicament
• Public title: F17464 in Acute Schizophrenia Trial FAST
• Scientific title: Effects of F17464 in Acute Exacerbation of Schizophrenia
• Date of first enrolment: June 2014
• Target sample size: 158
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02151656
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

France, Hungary, Latvia, Romania, Russian Federation

Contacts

• Name: Françoise TONNER, MD
• Affiliation: Pierre Fabre Medicament

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 64 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Schizophrenia

Intervention(s)

Drug: Placebo

Drug: F17464

Primary Outcome(s)

Change of the Positive and Negative Syndrome Scale (PANSS) total score [Time Frame: Day 43]

Secondary ID(s)

2013-005451-32

F17464 GE 2 01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors