F17464 in Acute Schizophrenia Trial (FAST)

• ClinicalTrials.gov Identifier: NCT02151656
• Recruitment Status: Completed
• First Posted: May 30, 2014
• Last Update Posted: December 16, 2016
• Sponsor: Pierre Fabre Medicament
• Information provided by (Responsible Party): Pierre Fabre Medicament

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Schizophrenia	Drug: F17464; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 158 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects of F17464 in Acute Exacerbation of Schizophrenia
• Study Start Date: June 2014
• Actual Primary Completion Date: December 2015
• Actual Study Completion Date: December 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: F17464; Oral administration - During 6 weeks - 4 capsules daily	Drug: F17464
Placebo Comparator: Placebo; Oral administration - During 6 weeks - 4 capsules daily	Drug: Placebo

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 64 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

France

Nîmes, France

Sotteville les Rouen, France

Hungary

Balassagyarm At, Hungary

Budapest, Hungary

Gyula, Hungary

Latvia

Daugavpils, Latvia

Jelgava, Latvia

Liepaja, Latvia

Strenci, Latvia

Romania

Arad, Romania

Bucharest, Romania

Campulum G Muscel, Romania

Craiova, Romania

Galati, Romania

Iasi, Romania

Sibiu, Romania

Targoviste, Romania

Targu-Mures, Romania

Timisoara, Romania

Russian Federation

Arkhangelsky district, Russian Federation

Ekaterinburg, Russian Federation

Engels, Russian Federation

Kazan, Russian Federation

Moscow, Russian Federation

Orenburg, Russian Federation

Saratov, Russian Federation

Tomsk, Russian Federation

Sponsors and Collaborators

Pierre Fabre Medicament

Investigators

• Study Director: Françoise TONNER, MD; Pierre Fabre Medicament

More Information

• Responsible Party: Pierre Fabre Medicament
• ClinicalTrials.gov Identifier: NCT02151656
• Other Study ID Numbers: F17464 GE 2 01; 2013-005451-32 ( EudraCT Number )
• First Posted: May 30, 2014
• Last Update Posted: December 16, 2016
• Last Verified: January 2016

Keywords provided by Pierre Fabre Medicament:

Schizophrenia; Mental disorders; Antipsychotic Drugs

Additional relevant MeSH terms:

Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders