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F17464 in Acute Schizophrenia Trial (FAST)

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

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

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



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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02151656


Locations
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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
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Study Director: Françoise TONNER, MD Pierre Fabre Medicament

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Responsible Party: Pierre Fabre Medicament
ClinicalTrials.gov Identifier: NCT02151656     History of Changes
Other Study ID Numbers: F17464 GE 2 01
2013-005451-32 ( EudraCT Number )
First Posted: May 30, 2014    Key Record Dates
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:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders