Clinical trial NCT02151656: F17464 in Acute Schizophrenia Trial
Official title: Effects of F17464 in Acute Exacerbation of Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: Schizophrenia
Mental disorders
Antipsychotic Drugs
Lead sponsor: Pierre Fabre Medicament
Sponsor class: INDUSTRY
First posted: 2014-05-30
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
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 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

Primary outcomes:
measure: Change of the Positive and Negative Syndrome Scale (PANSS) total score
timeFrame: Day 43
Secondary outcomes:
Other outcomes:
Locations:
city: Nîmes
country: France
city: Sotteville les Rouen
country: France
city: Balassagyarm At
country: Hungary
city: Budapest
country: Hungary
city: Gyula
country: Hungary
city: Daugavpils
country: Latvia
city: Jelgava
country: Latvia
city: Liepaja
country: Latvia
city: Strenci
country: Latvia
city: Arad
country: Romania
city: Bucharest
country: Romania
city: Campulum G Muscel
country: Romania
city: Craiova
country: Romania
city: Galati
country: Romania
city: Iasi
country: Romania
city: Sibiu
country: Romania
city: Targoviste
country: Romania
city: Targu-Mures
country: Romania
city: Timisoara
country: Romania
city: Arkhangelsky district
country: Russian Federation
city: Ekaterinburg
country: Russian Federation
city: Engels
country: Russian Federation
city: Kazan
country: Russian Federation
city: Moscow
country: Russian Federation
city: Orenburg
country: Russian Federation
city: Saratov
country: Russian Federation
city: Tomsk
country: Russian Federation
Study officials:
affiliation: Pierre Fabre Medicament
name: Françoise TONNER, MD
role: STUDY_DIRECTOR
References: